Methods and compositions for collection and preservation of biologicals

ABSTRACT

Provided herein are compositions and methods of use thereof for collection, preservation and/or extraction of biologicals from a subject. For example, a solution that enables collection, preservation, and extraction of nucleic acids in a single step, and methods of using such solution are provided. In some embodiments, the compositions, kits, and methods are useful for the collection and analysis of samples from patients that have or are suspected of having SARS-CoV-2 virus that can cause Covid-19.

BACKGROUND OF THE INVENTION

PCT Patent Application No. WO/2020/023630 discloses “a preservationmixture comprising an iron chelator, wherein the preservation mixture isconfigured to preserve nucleic acid molecules in a urine sample andprevent growth of microbes in the sample.”

U.S. Pat. No. 8,470,536 discloses “compositions and methods forisolation and storage of nucleic acids from bodily fluids, such assaliva, for detection of nucleotide sequences. More specifically, theinvention relates to compositions and methods that do not require aseparate step for extraction of nucleic acids prior to use in nucleicacid amplification reactions.”

US Patent Application No. US20190062806 discloses “compositions forpreserving, stabilizing, and/or preparing nucleic acid in a biologicalsample.” US Patent Application No. 20150218653 discloses “a kit . . .comprising: a) magnetic particles, wherein the surface of the magneticparticles comprise anion exchange moieties; b) a denaturation agentwhich is an alkaline solution comprising a base, preferably NaOH or KOH;and c) a composition comprising a chaotropic agent and optionally one ormore additives selected from the group of chelating agents, bufferingagents and preservatives.”

SUMMARY OF THE INVENTION

The instant disclosure is based, at least in part, on the discovery ofsolutions for collecting/storing nucleic acids that improve stability ofnucleic acids. Further, the disclosure is also based, in part, on thediscovery that nucleic acids from a biological sample can be preservedand extracted using a single solution. In various aspects andembodiments, the disclosure may relate to a nucleic acid enhancedpreservation media with integrated extraction steps.

In illustrative embodiments, the disclosure provides embodiments 1-171noted below.

DETAILED DESCRIPTION OF THE INVENTION

The instant disclosure is based, at least in part, on the discovery ofsolutions for collecting/storing nucleic acids that improve stability ofnucleic acids. Further, the disclosure is also based, in part, on thediscovery that nucleic acids from a biological sample can be preservedand extracted using a single solution. In various aspects andembodiments, the disclosure may relate to a nucleic acid enhancedpreservation media with integrated extraction steps. Due the unstablenature of cell-free nucleic acids, accurate and reproducible screeningcan be difficult with existing sample preservation solutions, thus insome embodiments the disclosure relates to solutions that have improvedproperties with regard to stability of nucleic acid during storage. Invarious embodiments, the disclosure may relate to methods that involvecollecting a biological sample from a subject, contacting the samplewith a preservation media such as described herein, extracting nucleicacids from the sample using magnetic beads, and isolating those beadsfor downstream analysis.

In some embodiments, the solutions, kits and methods provided herein maybe useful for collecting, storing and/or extracting samples that have,or may have, nucleic acid. In some embodiments, the solutions, kits andmethods may be useful for collecting, storing and/or extracting samplesthat have, are suspected of having, or at risk of having nucleic acid,for example, nucleic acid from a pathogen. In this regard, thesolutions, kits, and methods may in certain embodiments reduce the“false negative” rate of assays and diagnostics designed to detectpathogen nucleic acid in a sample. Importantly, in 2019, 2020, andperhaps later, the world has been victim of a severe COVID-19 pandemiccaused by the RNA-based SARS-CoV-2 virus. One of the challenges ofattempts to reign in the COVID-19 has been to establish effective testsand diagnostics for detecting SARS-CoV-2 RNA in samples collected fromsubjects that have or may have the virus. These challenges are broughtabout, at least in part, by the difficulty to collect, store, andtransport samples without resulting in the degradation of the viral RNA.Viral RNA degradation during collection, storage, and/or transport canresult in false-negative test results in the subsequent nucleic acidevaluation methods (e.g. PCR, NexGen sequencing, etc.) that, in turn,can result in further spread of the virus in populations around theworld. Thus, in certain aspects and embodiments the present disclosureis intended to provide solutions, kits, and methods that improve theability to collect, store, and transport samples having nucleic acid(such as SARS-CoV-2 RNA), such that the nucleic acid remainssufficiently stable for subsequent analysis. Another challenge inCOVID-19 testing arose from the fact that the pandemic resulted in adramatic increase in the world-wide demand for nucleic acid-baseddiagnostics as well as the volume of samples being processed andevaluated daily. Thus, it is an additional objective of some of theembodiments of the present disclosure to increase the efficiency andlower the cost of nucleic acid diagnostics. Generally, in the process ofnucleic acid preservation and extraction, one solution is used for thepreservation, storage and/or transport of a nucleic acid and a separatesolution is used to extract the nucleic acids from sample—thistwo-solution process can often involve an increase in cost and laborrequired. Along these lines, some of the embodiments of solutions, kits,and methods provided herein allow for nucleic acid (such as SARS-CoV2RNA) to be stably preserved and extracted from a sample using a singlepreservation/extraction solution. In some embodiments of the solutions,kits, and methods presented herein, paramagnetic beads present in asolution of the disclosure bind nucleic acids from a sample and canfacilitate nucleic acid extraction. Further, certain embodiments of thesolutions, kits, and methods provided herein are particularly useful inhigh-throughput nucleic acid processing and evaluation. In someembodiments, the ability to use a single solution for sample collectionand extraction allows for all of the sample (and its nucleic acid) to besubjected to nucleic acid analysis-such embodiments may increase theamount of tested nucleic acid, and in turn, increasing analysissensitivity.

As used herein, the term “nucleic acid” refers to polynucleotides suchas deoxyribonucleic acid (DNA) or ribonucleic acid (RNA). Nucleic acidsinclude but are not limited to genomic DNA, cDNA, mRNA, iRNA, miRNA,tRNA, ncRNA, rRNA, aptamers, plasmids, anti-sense DNA strands, shRNA,ribozymes, nucleic acids conjugated and oligonucleotides. Nucleic acidof the disclosure may be naturally occurring or recombinantly producedor chemically synthesized. Nucleic acid may be present as asingle-stranded or double-stranded and linear or covalently circularlyclosed molecule.

Accordingly, in a first aspect, provided is a solution that includes achelating agent, a detergent, a salt, a cationic polymer and a pHbuffering agent. In some embodiments, a solution as provided hereinincludes a first and second chelating agent, a first and seconddetergent, a salt, a cationic polymer and a pH buffering agent. In someembodiments, the solution further includes paramagnetic beads. In someembodiments the solution further includes an antimicrobial. In someembodiments, a solution of the disclosure includes a chelating agent, adetergent, a salt, a cationic polymer, a pH buffering agent, a crowdingagent and paramagnetic beads. In some embodiments, the solution includesa chelating agent, a detergent, a salt, a cationic polymer, a pHbuffering agent and an antimicrobial. In some embodiments, a solution isprovided that includes (1) a chelating agent (or two or more chelatingagents), (2) a detergent (or two or more detergents), (3) a salt, (4) acationic polymer, (5) a pH buffering agent, (6) a crowding agent, (7)paramagnetic beads and (8) an antimicrobial.

In some embodiments, the solution of any one of the aspects orembodiments provided herein includes one or more chelating agents. Insome embodiments, the chelating agent[s] is configured to preservenucleic acid molecules in a sample and prevent growth of microbes in thesample. In some embodiments, the chelating agent is an iron chelator. Insome embodiments, the solution of any one of the aspects or embodimentsprovided herein includes one or more chelating agents selected from thegroup consisting of enterobactin, deferasirox (DFS), deferiprone (DFP),deferoxamine mesylate (DFM), EDTA, and EGTA. In some embodiments, thesolution of any one of the aspects or embodiments provided hereinincludes enterobactin as a chelating agent. In some embodiments, thesolution of any one of the aspects or embodiments provided hereinincludes deferasirox as a chelating agent. In some embodiments, thesolution of any one of the aspects or embodiments provided hereinincludes deferiprone as a chelating agent. In some embodiments, thesolution of any one of the aspects or embodiments provided hereinincludes deferoxamine mesylate as a chelating agent. In someembodiments, the solution of any one of the aspects or embodimentsprovided herein includes EDTA as a chelating agent. In some embodiments,the solution of any one of the aspects or embodiments provided hereinincludes EGTA as a chelating agent. In some embodiments the solutionincludes a first and second chelating agent (where agents are describedherein as a first and second of a class of agent, it is inferred thatthe first agent and second agent are different). In some embodiments,the solution of any one of the aspects or embodiments provided hereinincludes two or more chelating agents selected from the group consistingof enterobactin, deferasirox (DFS), deferiprone (DFP), deferoxaminemesylate (DFM), EDTA, and EGTA. In some embodiments, the solution of anyof the aspects and embodiments provided herein includes a chelatingagent present in the solution in an amount that is between 25-750 μM. Insome embodiments, the solution of any of the aspects and embodimentsprovided herein includes a chelating agent that is between 1-1,000 μM;or 10-50 μM; or 50-100 μM; or 100-200 μM; 100-150 μm; or 200-300 μM; or300-400 μM; or 400-500 μM; or 500-600 μM; or 600-700 μM; or 700-800 μM;or 800-900 μM; or 900-1000 μM; or 50-250 μM; or 100-150 μM; or 50-600μM; or 100-500 μM; or about 70 μM; or about 75 μM; or about 80 μM; orabout 90 μM; or about 100 μM; or about 110 μM; or about 120 μM; or about125 μM; or about 130 μM; or about 140 μM; or about 150 μM; or about 175μM; or about 200 μM; or about 250 μM; or about 300 μM; or about 400 μM;or about 500 μM in the solution. In some embodiments, the solution ofany of the aspects and embodiments provided herein includes a chelatingagent that is between 1-100 mM in the solution. In some embodiments, thesolution of any of the aspects and embodiments provided herein includesa chelating agent that is between 1-1,000 mM; or 10-50 mM; or 50-100 mM;or 100-200 mM; or 25-75 mM; or 50-55 mM; or 55-60 mM; or 60-65 mM; or65-70 mM; or 70-75 mM; or 75-80 mM; or 85-90 mM; or 90-95 mM; or 95-100mM; or 100-125 mM; or 125-150 mM; or about 10 mM; or about 25 mM; orabout 50 mM; or about 52.5 mM; or about 55 mM; or about 57.5 mM; orabout 60 mM; or about 62.5 mM; or about 65 mM; or about 67.5 mM; orabout 70 mM; or about 72.5 mM; or about 75 mM; or about 77.5 mM; orabout 80 mM; or about 85 mM; or about 90 mM; or about 95 mM; or about100 mM; or about 125 mM or about 150 mM; or about 175 mM; or about 200mM in the solution. In some embodiments, a solution as provided hereinincludes a first chelating agent and a second chelating agent; whereinthe first chelating agent is present in an amount that is 1-1,000 μM; or10-50 μM; or 50-100 μM; or 100-200 μM; 100-150 μm; or 200-300 μM; or300-400 μM; or 400-500 μM; or 500-600 μM; or 600-700 μM; or 700-800 μM;or 800-900 μM; or 900-1000 μM; or 50-600 μM; or 100-500 μM; or about 70μM; or about 75 μM; or about 80 μM; or about 90 μM; or about 100 μM; orabout 110 μM; or about 120 μM; or about 125 μM; or about 130 μM; orabout 140 μM; or about 150 μM; or about 175 μM; or about 200 μM; orabout 250 μM; or about 300 μM; or about 400 μM; or about 500 μM in thesolution; and the second chelating agent is present in an amount that is1-1,000 mM; or 10-50 mM; or 50-100 mM; or 100-200 mM; or 25-75 mM; or50-55 mM; or 55-60 mM; or 60-65 mM; or 65-70 mM; or 70-75 mM; or 75-80mM; or 85-90 mM; or 90-95 mM; or 95-100 mM; or 100-125 mM; or 125-150mM; or about 10 mM; or about 25 mM; or about 50 mM; or about 52.5 mM; orabout 55 mM; or about 57.5 mM; or about 60 mM; or about 62.5 mM; orabout 65 mM; or about 67.5 mM; or about 70 mM; or about 72.5 mM; orabout 75 mM; or about 77.5 mM; or about 80 mM; or about 85 mM; or about90 mM; or about 95 mM; or about 100 mM; or about 125 mM or about 150 mM;or about 175 mM; or about 200 mM in the solution. In some embodiments ofthe solutions provided herein, the solution includes EDTA as a chelatingagent; wherein the EDTA is present in the solution in an amount that is1-1,000 mM; or 10-50 mM; or 50-100 mM; or 100-200 mM; or 25-75 mM; or50-55 mM; or 55-60 mM; or 60-65 mM; or 65-70 mM; or 70-75 mM; or 75-80mM; or 85-90 mM; or 90-95 mM; or 95-100 mM; or 100-125 mM; or 125-150mM; or 55-75 mM; or about 10 mM; or about 25 mM; or about 50 mM; orabout 52.5 mM; or about 55 mM; or about 57.5 mM; or about 60 mM; orabout 62.5 mM; or about 65 mM; or about 67.5 mM; or about 70 mM; orabout 72.5 mM; or about 75 mM; or about 77.5 mM; or about 80 mM; orabout 85 mM; or about 90 mM; or about 95 mM; or about 100 mM; or about125 mM or about 150 mM; or about 175 mM; or about 200 mM in thesolution. In some embodiments of the solutions provided herein, thesolution includes DFM as a chelating agent; wherein the DFM is presentin the solution in an amount that is 1-1,000 μM; or 10-50 μM; or 50-100μM; or 100-200 μM; 100-150 μm; or 200-300 μM; or 300-400 μM; or 400-500μM; or 500-600 μM; or 600-700 μM; or 700-800 μM; or 800-900 μM; or900-1000 μM; or 50-600 μM; or 100-500 μM; or about 70 μM; or about 75μM; or about 80 μM; or about 90 μM; or about 100 μM; or about 110 μM; orabout 120 μM; or about 125 μM; or about 130 μM; or about 140 μM; orabout 150 μM; or about 175 μM; or about 200 μM; or about 250 μM; orabout 300 μM; or about 400 μM; or about 500 μM in the solution In someembodiments, the first chelator has a first binding affinity for a firstmetal and the second chelator has a second binding affinity for thefirst metal, the first binding affinity being greater than the secondbinding affinity. In some embodiments, the first metal comprises one ormore member(s) selected from the group consisting of: vanadium (V),chromium (Cr), manganese (Mn), iron (Fe), cobalt (Co), copper (Cu), zinc(Zn), and molybdenum (Mo). In some embodiments, the first chelator has athird binding affinity for a second metal and the second chelator has afourth binding affinity for the second metal, the second metal beingdifferent from the first metal, and the third binding affinity beingless than the fourth binding affinity. In some embodiments, the firstchelator comprises one or more member(s) selected from the groupconsisting of: a siderophore, a nucleoside monophosphate, a nucleosidediphosphate, a nucleoside triphosphate, and a functional variantthereof. In some embodiments, the siderophore comprises one or moremember(s) selected from the group consisting of: Achromobactina,Acinetobactin, Acinetoferrin, Aerobactin, Aeruginic acid, Agrobactin,Agrobactin A, Albomycin, Alcaligin, Alterobactin A, Alterobactin A,Aminochelin, Amonabactin P693, Amonabactin P750, Amonabactin T732,Amonabactin T789, Amphibactin B, Amphibactin C, Amphibactin D,Amphibactin E, Amphibactin F, Amphibactin G, Amphibactin H, AmphibactinI, Amphibactin S, Amphibactin T, Amphi-enterobactin, Amphi-enterobactinC12-OH, Amycolachrome, Anachelin 1, Anachelin 2, Anguibactin, AquachelinA, Aquachelin B, Aquachelin C, Aquachelin D, Aquachelin I, Aquachelin J,Arthrobactin, Asperchrome A, Asperchrome B1, Asperchrome B2, AsperchromeB3, Asperchrome C, Asperchrome D1, Asperchrome D2, Asperchrome D3,Asperchrome E, Asperchrome F1, Asperchrome F2, Asperchrome F3,Aspergillic acid, Avenic acid, Azotobactin, Azotobactin 87, AzotobactinD, Azotochelin, Azoverdin, Bacillibactin, Basidiochrome, Bisucaberin,Carboxymycobactin, Carboxymycobactin 1, Carboxymycobactin 2,Carboxymycobactin 3, Carboxymycobactin 4, Cepabactin, Chrysobactin,Citrate, Coelichelin, Coprogen, Coprogen B, Corynebactin,Deoxydistichonic acid, 2′-Deoxymugineic acid, Deoxyschizokinen,Des(diserylglycyl)-ferrirhodin, Desacetylcoprogen, DeferoxamineMesylate, Desferrioxamine A1A, Desferrioxamine A1B, Desferrioxamine A2,Desferrioxamine B, Desferrioxamine D1, Desferrioxamine D2,Desferrioxamine E, Desferrioxamine Et1, Desferrioxamine Et2,Desferrioxamine Et3, Desferrioxamine G1, Desferrioxamine G2A,Desferrioxamine G2B, Desferrioxamine G2C, Desferrioxamine H,Desferrioxamine N, Desferrioxamine P1, Desferrioxamine T1,Desferrioxamine T2, Desferrioxamine T3, Desferrioxamine T7,Desferrioxamine T8, Desferrioxamine Te1, Desferrioxamine Te2,Desferrioxamine Te3, Desferrioxamine X1, Desferrioxamine X2,Desferrioxamine X3, Desferrioxamine X4, Desferrithiocin,2,3-Dihydroxybenzoylserine, Dimerum acid, Dimethylcoprogen,Dimethylneocoprogen I, Dimethyltriomicin, Distichonic acid,E,E-putrebactene, Enantio Rhizoferrin, Enantio-Pyochelin, Enterobactin,Enterochelin, E-putrebactene, Exochelin MN, Exochelin MS, Ferrichrome,Ferrichrome A, Ferrichrome C, Ferrichrysin, Ferricrocin, Ferrimycin A,Ferrirhodin, Ferrirubin, Ferrocin A, Fimsbactin A, Fimsbactin B,Fimsbactin C, Fimsbactin D, Fimsbactin E, Fimsbactin F, Fluvibactin,Formobactin, Fusarinine, Fusarinine A, Fusarinine B, Fusarinine C,Heterobactin A, Heterobactin B, Hydroxycopropen, HydroxyisoneocoprogenI, 3-Hydroxymugineic acid, Hydroxy-neocoprogen I, Isoneocoprogen I,Isopyoverdin 10.7, Isopyoverdin 6.7, Isopyoverdin 7.13, Isopyoverdin90-33, Isopyoverdin 90-44, Isopyoverdin BTP1, Isotriornicin, Itoic acid,Loihichelin A, Loihichelin B, Loihichelin C, Loihichelin D, LoihichelinE, Loihichelin F, Maduraferrin, Malonichrome, Marinobactin,Marinobactin, Marinobactin, Marinobactin, Marinobactin, Marinobactin,Micacocidin, Moanachelins, Moanachelins, Moanachelins, Moanachelins,Moanachelins, Monoglucosylated, Mugineic, Mycobactin A, Mycobactin Av,Mycobactin F, Mycobactin H, Mycobactin J, Mycobactin M, Mycobactin N,Mycobactin NA, Mycobactin P, Mycobactin R, Mycobactin S, Mycobactin T,Myxochelin, Nannochelin A, Nannochelin B, Nannochelin C, Neocoprogen I,Neocoprogen II, Neurosporin, Nocobactin, Ochrobactin A, Ochrobactin B,Ochrobactin C, Ornibactin-C4, Omibactin-C6, Ornibactin-C8,Ornicorrugatin, Palmitoylcoprogen, Parabactin, Parabactin A,Petrobactin, Petrobactin disulphonate, Petrobactin sulphonate,Pistillarin, Protochelin, Pseudoalterobactin A, Pseudoalterobactin B,Pseudobactin, Pseudobactin 589A, Putrebactin, Pyochelin, Pyoverdin 1,Pyoverdin 10.1, Pyoverdin 10.10, Pyoverdin 10.2, Pyoverdin 10.3,Pyoverdin 10.4, Pyoverdin 10.5, Pyoverdin 10.6, Pyoverdin 10.8,Pyoverdin 10.9, Pyoverdin 11.1, Pyoverdin 11.2, Pyoverdin 11370,Pyoverdin 12, Pyoverdin 12.1, Pyoverdin 12.2, Pyoverdin 13525, Pyoverdin1547, Pyoverdin 17400, Pyoverdin 18-1, Pyoverdin 19310, Pyoverdin 2192,Pyoverdin 2392, Pyoverdin 2461, Pyoverdin 2798, Pyoverdin 51W, Pyoverdin6.1, Pyoverdin 6.2, Pyoverdin 6.3, Pyoverdin 6.4, Pyoverdin 6.5,Pyoverdin 6.6, Pyoverdin 6.8, Pyoverdin 7.1, Pyoverdin 7.10, Pyoverdin7.11, Pyoverdin 7.12, Pyoverdin 7.14, Pyoverdin 7.15, Pyoverdin 7.16,Pyoverdin 7.17, Pyoverdin 7.18, Pyoverdin 7.19, Pyoverdin 7.2, Pyoverdin7.3, Pyoverdin 7.4, Pyoverdin 7.5, Pyoverdin 7.6, Pyoverdin 7.7,Pyoverdin 7.8, Pyoverdin 7.9, Pyoverdin 8.1, Pyoverdin 8.2, Pyoverdin8.3, Pyoverdin 8.4, Pyoverdin 8.5, Pyoverdin 8.6, Pyoverdin 8.7,Pyoverdin 8.8, Pyoverdin 8.9, Pyoverdin 9.1, Pyoverdin 9.10, Pyoverdin9.11, Pyoverdin 9.12, Pyoverdin 9.2, Pyoverdin 9.3, Pyoverdin 9.4,Pyoverdin 9.5, Pyoverdin 9.6, Pyoverdin 9.7, Pyoverdin 9.8, Pyoverdin9.9, Pyoverdin 90-51, Pyoverdin 95-275, Pyoverdin 96-312, Pyoverdin96-318, Pyoverdin 9AW, Pyoverdin A214, Pyoverdin BTP2, Pyoverdin C,Pyoverdin CHAO, Pyoverdin D-TR133, Pyoverdin E, Pyoverdin G, PyoverdinGM, Pyoverdin I-III, Pyoverdin P19, Pyoverdin Pau, Pyoverdin PL8,Pyoverdin PVD, Pyoverdin R′, Pyoverdin Thai, Pyoverdin TII, Pyridoxatin,Quinolobactin, Rhizobactin, Rhizobactin 1021, Rhizoferrin, Rhizoferrinanalogues, Rhodotrulic acid, Sake Colorant A, Salmochelin S1,Salmochelin S2, Salmochelin S4, Salmochelin SX, Salmycin A, Schizokinen,Serratiochelin, Siderochelin A, Snychobactin A, Snychobactin B,Snychobactin C, Staphyloferrin A, Staphyloferrin B, Taiwachelin,Tetraglycine ferrichrome, Thiazostatin, Triacetylfusarine, Triomicin,Vibriobactin, Vibrioferrin, Vicibactin, Vulnibactin, and Yersiniabactin.In some embodiments, the second chelator comprises one or more member(s)selected from the group consisting of: ethylenediamintetraacetic acid(EDTA), nitrilotriacetic acid (NTA),trans-1,2-cyclohexanediaminetetraacetic acid (CyDTA),diethylenetriaminepentaacetic acid (DTPA), glycoletherdiaminetetraaceticacid (GEDTA), triethylenetetramine-N,N,N′,N″,N′″,N″″-hexaacetic acid(TTHA), dihydroxyethylglycine (DHEG), iminodiacetic acid (IDA),nitrilotrimethylphosphonic acid (NTP), N-(2-hydroxyethyl)iminodiaceticacid (HIDA), ethylenediamine-N,N′-dipropionic acid (EDDP),ethylenediaminetetra(methylenephosphonic) acid (EDTPO),nitrilotrimethylphosphonic acid (NTP) and1,2-bis(o-aminophenoxy)ethane-N,N,N′,N′-tetraacetic acid (BAPTA).

In some embodiments, a solution of the disclosure includes a detergentwherein the detergent is one or more selected from the group consistingof cholate, deoxycholate, sodium dodecyl sulfate, sarkosyl, DDM,digitonin, NP-40, Triton X-100, Tween 20, and Tween 80. In someembodiments, a solution of any of the aspects and embodiments providedherein includes a detergent wherein the detergent is cholate. In someembodiments, a solution of any of the aspects and embodiments providedherein includes a detergent wherein the detergent is deoxycholate. Insome embodiments, a solution of any of the aspects and embodimentsprovided herein includes a detergent wherein the detergent is sodiumdodecyl sulfate. In some embodiments, a solution of any of the aspectsand embodiments provided herein includes a detergent wherein thedetergent is sarkosyl. In some embodiments, a solution of any of theaspects and embodiments provided herein includes a detergent wherein thedetergent is DDM. In some embodiments, a solution of any of the aspectsand embodiments provided herein includes a detergent wherein thedetergent is digitonin. In some embodiments, a solution of any of theaspects and embodiments provided herein includes a detergent wherein thedetergent is NP-40. In some embodiments, a solution of any of theaspects and embodiments provided herein includes a detergent wherein thedetergent is Triton X-100(2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethanol). In some embodiments,a solution of any of the aspects and embodiments provided hereinincludes a detergent wherein the detergent is Tween 20. In someembodiments, a solution of any of the aspects and embodiments providedherein includes a detergent wherein the detergent is Tween 80. In someembodiments the detergent is present in the solution in an amount thatis 0.1-1.0%; or about 0.1-0.5%; or about 0.5-1.0%; or 0.2-0.8%; or0.3-0.7%; or 0.4-0.6%; or about 0.1%; or about 0.2%; or about 0.3%; orabout 0.4%; or about 0.5%; or about 0.6%; or about 0.7%; or about 0.8%;or about 0.9%; or about 1.0% weight/volume of the solution. In someembodiments the total amount of one or more detergents is present in thesolution in an amount that is 0.1-1.0%; or about 0.1-0.5%; or about0.5-1.0%; or 0.2-0.8%; or 0.3-0.7%; or 0.4-0.6%; 0.1-2.0%; or about0.5-0.1.5%; or about 0.75-1.25%; or about 0.1%; or about 0.2%; or about0.3%; or about 0.4%; or about 0.5%; or about 0.6%; or about 0.7%; orabout 0.8%; or about 0.9%; or about 1.0%; or about 1.1%; or about 1.2%;or about 1.25%; or about 1.3%; or about 1.4%; or about 1.5%; or about1.6%; or about 1.7%; or about 1.75%; or about 1.8%; or about 1.9%; orabout 2% weight/volume of the solution. In some embodiments, a solutionof any of the aspects and embodiments provided herein includes cholatein an amount between 0.1-0.5%; or about 0.1% or about 0.2%; or about0.3%; or about 0.4%; or about 0.5% weight/volume of the solution. Insome embodiments, a solution of any of the aspects and embodimentsprovided herein includes Deoxycholate in an amount between 0.1-0.5%; orabout 0.1%; or about 0.2%; or about 0.3%; or about 0.4%; or about 0.5%weight/volume of the solution. In some embodiments, a solution of any ofthe aspects and embodiments provided herein includes Sodium DodecylSulfate (SDS) in an amount between 0.1-1.0%; or about 0.1-0.5%; or about0.5-1.0%; or 0.2-0.8%; or 0.3-0.7%; or 0.4-0.6%; or about 0.1%; or about0.2%; or about 0.3%; or about 0.4%; or about 0.5%; or about 0.6%; orabout 0.7%; or about 0.8%; or about 0.9%; or about 1.0% weight/volume ofthe solution. In some embodiments, a solution of any of the aspects andembodiments provided herein includes Sarkosyl in an amount between0.05-0.5%; or 0.05-0.1%; or 0.075-0.125%; or 0.2-0.4%; or about 0.05%;or about 0.1%; or about 0.2%; or about 0.3%; or about 0.4%; or about0.5% weight/volume of the solution. In some embodiments, a solution ofany of the aspects and embodiments provided herein includes DDM in anamount between 0.1-1.0%; or 0.2-1.0%; or about 0.1-0.5%; or about0.5-1.0%; or 0.3-0.7%; or 0.4-0.6%; or about 0.1%; or about 0.2%; orabout 0.3%; or about 0.4%; or about 0.5%; or about 0.6%; or about 0.7%;or about 0.8%; or about 0.9%; or about 1.0% weight/volume of thesolution. In some embodiments, a solution of any of the aspects andembodiments provided herein includes digitonin in an amount between0.2-2.0%; or 0.2-1.0%; or 0.3-0.7%; or 0.18-1.2%; or 0.5-1.5%; or1.0-2.0%; or about 0.2%; 0.3%; or about 0.4%; or about 0.5%; or about0.6%; or about 0.7%; or about 0.8%; or about 0.9%; or about 1.0%; orabout 1.2%; or about 1.5%; or about 1.8%; or about 2% weight/volume ofthe solution. In some embodiments, a solution of any of the aspects andembodiments provided herein includes NP-40 in an amount between0.05-1.0%; or 0.05-0.1%; or 0.075-0.125%; or 0.2-0.4%; 0.1-0.5%; orabout 0.5-1.0%; or 0.3-0.6%; or about 0.05%; or about 0.1%; or about0.2%; or about 0.3%; or about 0.4%; or about 0.5%; or about 0.7%; orabout 0.8%; or about 0.9%; or about 1.0% weight/volume of the solution.In some embodiments, a solution of any of the aspects and embodimentsprovided herein includes Triton X-100 in an amount between 0.1-1.0%; orabout 0.1-0.5%; or about 0.5-1.0%; or 0.2-0.8%; or 0.3-0.7%; or0.4-0.6%; or about 0.1%; or about 0.2%; or about 0.3%; or about 0.4%; orabout 0.5%; or about 0.6%; or about 0.7%; or about 0.8%; or about 0.9%;or about 1.0% weight/volume of the solution. In some embodiments, asolution of any of the aspects and embodiments provided herein includesTween 20 in an amount between 0.05-0.5%; or 0.05-0.1%; or 0.075-0.125%;or 0.2-0.4%; or about 0.05%; or about 0.1%; or about 0.2%; or about0.3%; or about 0.4%; or about 0.5% weight/volume of the solution. Insome embodiments, a solution of any of the aspects and embodimentsprovided herein includes Tween 80 in an amount between 0.05-0.5%; or0.05-0.1%; or 0.075-0.125%; or 0.2-0.4%; or about 0.05%; or about 0.1%;or about 0.2%; or about 0.3%; or about 0.4%; or about 0.5% weight/volumeof the solution. In some embodiments, a solution as provided hereinincludes two or more detergents, for example a first detergent and asecond detergent. In some embodiments a solution as provided hereinincludes a first and second detergent wherein the first and seconddetergent combined are present in the solution in an amount that is0.01-5%; or 0.1-0.5%; or 0.05%-0.1%; or 0.1%-0.5%; or 0.5%-1%; or 1%-2%;or 2%-3%; or 3%-4%; or 4%-5%; or 0.04-0.06%; or 0.08-0.12%; or0.13-0.17%; or 0.3-0.7%; or 0.75-1.25%; or 1-3%; or about 0.01%; orabout 0.025%; or about 0.05%; or about 0.075%; or about 0.1%; or about0.25%; or about 0.5%; or about 0.75%; or about 1%; or about 1.25%; orabout 1.5%, or about 2%; or about 3%; or about 4%; or about 5%weight/volume. In some embodiments having one or more detergents asprovided herein, the cumulative amounts of the one or more detergentsthat are present in the solution are present in an amount that is0.01-5%; or 0.1-0.5%; or 0.05-0.1%; or 0.1-0.5%; or 0.5-1%; or 1-2%; or2-3%; or 3%4%; or 4-5%; or 0.04-0.06%; or 0.08-0.12%; or 0.13-0.17%; or0.3-0.7%; or 0.75-1.25%; or 0.5-1.5%; or 1-3%; or about 0.01%; or about0.025%; or about 0.05%; or about 0.075%; or about 0.1%; or about 0.25%;or about 0.5%; or about 0.75%; or about 1%; or about 1.25%; or about1.5%, or about 2%; or about 3%; or about 4%; or about 5% weight/volume.In certain embodiments the solutions as provided herein include a firstdetergent and a second detergent; wherein one detergent is an ionicdetergent and one detergent is a non-ionic detergent. In someembodiments, a combinations of ionic and non-ionic detergents can createan emulsion that is insensitive to temperature changes and/or conferssolubility properties that do not exist with either detergent alone.These detergent emulsions can in some embodiments facilitate the lysisstep of nucleic acid extraction by disrupting membranes. In previousnucleic acid extraction solutions, a single ionic or non-ionic detergentis used to facilitate lysis or extraction, but it will generally is donein an extraction procedure that is step-wise and separates (1) samplecollection from (2) lysis, (3) nucleic acid extraction, and (4) washingof precipitated nucleic acid. To enable the integration of steps 1, 2,and 3 requires a specific combination of two detergents of differingphysical characteristics; in some embodiments of the solutions of thepresent disclosure one detergent is ionic and the other is non-ionic. Insolutions that include only an ionic detergent (without a non-ionicdetergent), the detergent may precipitation from solution throughcrystal formation; render the solution ineffective. In solutions thatinclude only a nonionic detergent (without an ionic detergent) thedetergent may also precipitate from solution, and greater detergentconcentration would be required to inactivate pathogen and facilitatelysis and extraction. Attempts to increase the concentration of thenonionic detergent may be ineffective as it would only increase the rateof precipitation from solution.

In certain embodiments, a solution of the disclosure includes a pHbuffering agent (ie a pH buffer). pH buffers are well known in the artand are generally used to maintain solution at or near a particular pHvalue. In certain embodiments one of ordinary skill in the art iscapable of creating a suitable pH buffer system that is suitable for asolution of the present disclosure. For instance, in some embodimentsthe pH buffer may maintain the solution of the disclosure at a pH of atleast about 7, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1,8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, or 9.0, or more. In someembodiments the pH buffer may maintain the solution at a pH of at mostabout 9.0, 8.9, 8.8, 8.7, 8.6, 8.5, 8.4, 8.3, 8.2, 8.1, 8.0, 7.9, 7.8,7.7, 7.6, 7.5, 7.4, 7.3, 7.2, 7.1, or 7.0, or less. The pH buffer maymaintain the preservation solution at a pH that is within a rangedefined by any two of the preceding values. For instance, in certainembodiments the pH buffer may maintain the preservation solution at a pHthat is 7-9; or 7-8; or 6-8; or 6-7; or 6.5-7.5; 6.75-7.25; or7.25-7.75; or 7.5-8.5; or 7.75-8.25; or 8-9; or 8.25-8.75; or about 7.1;or about 7.2; or about 7.3; or about 7.4; or about 7.5; or about 7.6; orabout 7.7; or about 7.8; or about 7.9; or about 8.0; or about 8.1, 8.2;or about 8.3; or about 8.4; or about 8.5; or about 8.6; or about 8.7; orabout 8.8; or about 8.9; or about; or about 9.0. The pH buffer may insome embodiments maintain the preservation solution at a pH of about 8.In some embodiments, a buffering agent is present in the solution in anamount that is 25-250 mM; or 50-200 mM; or 75-175 mM; or 100-150 mM; orabout 75 mM; or about 100 mM; or about 125 mM; or about 150 mM; or about175 mM. In some embodiments, the buffering agent is one or more selectedfrom the group consisting of a citrate buffer, a HEPES buffer, aphosphate buffer, and a Tris buffer. In some embodiments the bufferingagent is Tris-HCl. In some embodiments the pH buffering agent is acitrate buffer and is present in an amount between 50-250 mM. In someembodiments the pH buffering agent is a HEPES buffer and is present inan amount between 25-150 mM. In some embodiments the pH buffering agentis a phosphate buffer, and is present in an amount between 50-200 mM. Insome embodiments the pH buffering agent is a Tris buffer (for exampleTris-HCl), and is present in an amount between 25-250 mM. The pH buffermay mitigate degradation or fragmentation of nucleic acids contained inthe urine sample when the sample is subjected to freezing or defrosting.The pH buffer may in certain embodiments prevent nucleic acid basedamage, such as de-purination or deamination.

In some embodiments, a solution of the disclosure includes a crowdingagent. In some embodiments, a solution of the disclosure includes acrowding agent wherein the crowding agent is one or more selected fromthe group consisting of ethanol, isopropanol, and polyethylene glycol(PEG). In some embodiments, a solution of the disclosure includes acrowding agent wherein the crowding agent is PEG and wherein the PEG isone or more selected from the group consisting of PEG 4000, PEG6000, andPEG8000. In some embodiments, a solution of the disclosure includes acrowding agent wherein the crowding agent is one or more selected fromthe group consisting of ethanol, isopropanol, PEG 4000, PEG6000, andPEG8000. In some embodiments, a solution of the disclosure includes acrowding agent wherein the crowding agent is one or more selected fromthe group consisting of ethanol, isopropanol, PEG (e.g., PEG 4000,PEG6000, and/or PEG8000); and wherein the crowding agent is present inan amount between 10-20%; or 10-15%; or 15-20%; or 12-18%; or 13-17%; orabout 10%; or about 11%; or about 12%; or about 13%; or about 14%; orabout 15%; or about 16%; or about 17%; or about 18%; or about 19%; orabout 20% weight/volume of the solution. In some embodiments, a solutionof the present disclosure includes the crowding agent, ethanol, presentin an amount between 10-20%; or 10-15%; or 15-20%; or 12-18%; or 13-17%;or about 10%; or about 11%; or about 12%; or about 13%; or about 14%; orabout 15%; or about 16%; or about 17%; or about 18%; or about 19%; orabout 20% weight/volume of the solution. In some embodiments, a solutionof the present disclosure includes the crowding agent, isopropanol,present in an amount between 10-20%; or 10-15%; or 15-20%; or 12-18%; or13-17%; or about 10%; or about 11%; or about 12%; or about 13%; or about14%; or about 15%; or about 16%; or about 17%; or about 18%; or about19%; or about 20% weight/volume of the solution. In some embodiments, asolution of the present disclosure includes the crowding agent, PEG4000,present in an amount between 10-20%; or 10-15%; or 15-20%; or 12-18%; or13-17%; or about 10%; or about 11%; or about 12%; or about 13%; or about14%; or about 15%; or about 16%; or about 17%; or about 18%; or about19%; or about 20% weight/volume of the solution. In some embodiments, asolution of the present disclosure includes the crowding agent, PEG6000,present in an amount between 10-20%; or 10-15%; or 15-20%; or 12-18%; or13-17%; or about 10%; or about 11%; or about 12%; or about 13%; or about14%; or about 15%; or about 16%; or about 17%; or about 18%; or about19%; or about 20% weight/volume of the solution. In some embodiments, asolution of the present disclosure includes the crowding agent, PEG8000,present in an amount between 10-20%; or 10-15%; or 15-20%; or 12-18%; or13-17%; or about 10%; or about 11%; or about 12%; or about 13%; or about14%; or about 15%; or about 16%; or about 17%; or about 18%; or about19%; or about 20% weight/volume of the solution.

In some embodiments, a solution as provided herein includes a salt, orosmotic agent. In some embodiments, the type and amount of a salt, orosmotic agent, is present in a solution of the disclosure is optimizedfor preservation and/or evaluation of nucleic acid. In some embodiments,the salt, or osmotic agent, is present in the solution in an amount thatis 0.5-2.5M; or 1-2M; or 1.25-1.75M; or 1-1.5M; or 1.5-2M; or 1.5-2.5M;or 2-2.5M; or about 0.5M; or about 0.6M; or about 0.7M; or about 0.8M;or about 0.9M; or about 1.0M; or about 1.1M; or about 1.2M; or about1.3M; or about 1.4M; or about 1.5M; or about 1.6M; or about 1.7M; orabout 1.8M; or about 1.9M; or about 2.0M; or about 2.1M or about 2.2M;or about 2.3M; or about 2.4M; or about 2.5M. In some embodiments thesalt, or osmotic agent, is sodium chloride (NaCl). In some embodimentsthe salt, or osmotic agent, is sodium chloride (NaCl) present in anamount that is 0.5-2.5M; or 1-2M; or 1.25-1.75M; or 1-1.5M; or 1.5-2M;or 1.5-2.5M; or 2-2.5M; or about 0.5M; or about 0.6M; or about 0.7M; orabout 0.8M; or about 0.9M; or about 1.0M; or about 1.1M; or about 1.2M;or about 1.3M; or about 1.4M; or about 1.5M; or about 1.6M; or about1.7M; or about 1.8M; or about 1.9M; or about 2.0M; or about 2.1M orabout 2.2M; or about 2.3M; or about 2.4M; or about 2.5M.

In some embodiments, a solution as described herein is provided whereinthe solution includes a cationic polymer selected from the groupconsisting of Poly-L-Arginine, Poly-D-Lysine, and Poly-L-Lysine. In someembodiments, the solution of any embodiments herein includes a cationicpolymer selected from the group consisting of Poly-L-Arginine,Poly-D-Lysine, and Poly-L-Lysine; wherein the cationic polymer ispresent in the solution in an amount that is 1-100 μgg/mL; or 1-10μg/mL; or 10-20 μg/mL; or 20-30 μg/mL; or 30-40 μg/mL; or 40.50 μg/mL;or 50-60 μg/mL; or 60-70 μg/mL; or 70-80 μg/mL; or 80-90 μg/mL; or90-100 μg/mL; or 1-25 μg/mL; or 10-15 μg/mL; or about 8 μg/mL; or about10 μg/mL; or about 12.5 μg/mL; or about 15 μg/mL; or about 20 μg/mL; orabout 25 μg/mL or about 50 μg/mL; or about 75 μg/mL; or about 100 μg/mL.In some embodiments, a solution as described herein is provide whereinthe solution includes Poly-L-Arginine; wherein the Poly-L-Arginine has amolecular weight between 5,000-15,000. In some embodiments, a solutionas described herein is provide wherein the solution includesPoly-L-Arginine; wherein the Poly-L-Arginine has a molecular weightbetween 15,000-75,000. In some embodiments, a solution as describedherein is provide wherein the solution includes Poly-L-Arginine; whereinthe Poly-L-Arginine has a molecular weight is greater than 70,000. Insome embodiments, a solution as described herein is provide wherein thesolution includes Poly-D-Arginine; wherein the Poly-L-Arginine has amolecular weight greater than 300,000. In some embodiments, a solutionas described herein is provide wherein the solution includesPoly-L-Arginine; wherein the Poly-L-Arginine is present in the solutionin an amount that is 1-100 μg/mL; or 1-10 μg/mL; or 10-20 μg/mL; or20-30 μg/mL; or 30-40 μg/mL; or 40.50 μg/mL; or 50-60 μg/mL; or 60-70μg/mL; or 70-80 μg/mL; or 80-90 μg/mL; or 90-100 μg/mL; or 1-25 μg/mL;or 10-15 μg/mL; or about 8 μg/mL; or about 10 μg/mL; or about 12.5μg/mL; or about 15 μg/mL; or about 20 μg/mL; or about 25 μg/mL or about50 μg/mL; or about 75 μg/mL; or about 100 μg/mL. In some embodiments, asolution as described herein is provided wherein the solution includesPoly-L-Lysine; wherein the Poly-L-Lysine has a molecular weight between1,000-5,000. In some embodiments, a solution as described herein isprovide wherein the solution includes Poly-L-Lysine; wherein thePoly-L-Lysine has a molecular weight between 30,000-70,000. In someembodiments, a solution as described herein is provide wherein thesolution includes Poly-L-Lysine; wherein the Poly-L-Lysine has amolecular weight between 70,000-150,000. In some embodiments, a solutionas described herein is provide wherein the solution includesPoly-L-Lysine; wherein the Poly-L-Lysine has a molecular weight between150,000-300,000. In some embodiments, the poly-L-lysine may have amolecular weight of at least about 100 Daltons (Da), 200 Da, 300 Da, 400Da, 500 Da, 600 Da, 700 Da, 800 Da, 900 Da, 1,000 Da, 2,000 Da, 3,000Da, 4,000 Da, 5,000 Da, 6,000 Da, 7,000 Da, 8,000 Da, 9,000 Da, or10,000 Da, or more. The poly-L-lysine may have a molecular weight of atmost about 10,000 Da, 9,000 Da, 8,000 Da, 7,000 Da, 6,000 Da, 5,000 Da,4,000 Da, 3,000 Da, 2,000 Da, 1,000 Da, 900 Da, 800 Da, 700 Da, 600 Da,500 Da, 400 Da, 300 Da, 200 Da, or 100 Da, or less. The poly-L-lysinemay have molecular weight that is within a range defined by any two ofthe preceding values, and multiple species of different size ranges maybe included together in various ratios. For instance, the poly-L-lysinemay have a molecular weight that is within a range from 1,000 Da to5,000 Da. One preferred embodiment may include poly-L-lysine trimerswith a molecular weight of 402.53 Da. A combination of molecular weightsmay be used together to facilitate both cell membrane stabilization andoptimal DNA compaction. For example, various ratios of poly-L-lysinespecies may be used, such as about 10%, 20%, 30% 40% 50%, or 60% ofspecies being in the range of 1,000-5,000 Da and the other about 90%,80%, 70%, 60%, 50%, or 40% of species being in the range of around 400Da. In some embodiments, a solution as described herein is providedwherein the solution includes Poly-L-Lysine; wherein the Poly-L-Lysineis present in the solution in an amount that is 1-100 μg/mL; or 1-10μg/mL; or 10-20 μg/mL; or 20-30 μg/mL; or 30-40 μg/mL; or 40.50 μg/mL;or 50-60 μg/mL; or 60-70 μg/mL; or 70-80 μg/mL; or 80-90 μg/mL; or90-100 μg/mL; or 1-25 μg/mL; or 10-15 μg/mL; or about 8 μg/mL; or about10 μg/mL; or about 12.5 μg/mL; or about 15 μg/mL; or about 20 μg/mL; orabout 25 μg/mL or about 50 μg/mL; or about 75 μg/mL; or about 100 μg/mL.In some embodiments Poly-L-Lysine in a solution as provided herein mayprotect the nucleic acids by compacting free nucleic acids, such as byengaging in transient electrostatic or other charge-based associationswith the nucleic acids. In some embodiments, the Poly-L-Lysine many be aPoly-L-Lysine hydrobromide.

In some embodiments of the solutions provided herein the solutionincludes an antimicrobial. As used herein, an antimicrobial is an agentthat kills a microorganism, or stops or slows the growth or division ofa microorganism. In some embodiments, an antimicrobial is an antibiotic,antiviral or antimycotic. In some embodiments an antimicrobial isapproved by a government regulatory agency or authority (such as theUnited States Food and Drug Administration, U.S. FDA) as anantimicrobial, for example approved as an antibiotic, antiviral orantimycotic. In some embodiments the antimicrobial is one or moreselected from a group consisting of penicillin, streptomycin,Amphotericin B (Fungizone), and a urine Stabilur tablet. In certainembodiments of the solutions provided herein one or more antimicrobialsare present in the solution in an amount that is effective to kill amicroorganism or stops or slows the growth or division of amicroorganism. In certain embodiments of the solutions provided hereinone or more antimicrobials are present in the solution in an amount thatis effective to kill a microorganism, or stops or slows the growth ordivision of most or all microorganisms that could be in the solution. Insome embodiments, a solution as provided herein includes penicillin inan amount that is 25-250 Units/ml; or 50-200 Units/ml; or 100-150 Unitsper/ml; 50-75 Units/ml; or 70-80 Units/ml; or 80-90 Units/ml; or 90-100Units/ml; or 100-110 Units/ml; or 110-120 Units/ml; or 120-130 Units/ml;or 130-140 Units/ml; or 140-150 Units/ml; or 150-175 Units/ml; or about100 Units/ml; or about 125 Units/ml; or about 150 Units/ml; or about 175Units/ml. In some embodiments, a solution as provided herein includesstreptomycin in an amount that is 25-250 μg/ml; or 50-200 μg/ml; or100-150 μg per/ml; 50-75 μg/ml; or 70-80 μg/ml; or 80-90 μg/ml; or90-100 μg/ml; or 100-110 μg/ml; or 110-120 μg/ml; or 120-130 μg/ml; or130-140 μg/ml; or 140-150 μg/ml; or 150-175 μg/ml; or about 100 μg/ml;or about 125 μg/ml; or about 150 μg/ml; or about 175 μg/ml. In someembodiments, a solution as provided herein includes amphotericin B in anamount that is 100-500 ng/ml; or 200-400 ng/ml; or 100-200 ng/ml; or200-300 ng/ml; or 250-350 ng/ml; or 300-400 ng/ml; or 350-450 ng/ml; or400-500 ng/ml; or about 150 ng/ml; or about 175 ng/ml; or about 200ng/ml; or about 212 ng/ml; or about 225 ng/ml; or about 250 ng/ml; orabout 262 ng/ml; or about 275 ng/ml; or about 287 ng/ml; or about 300ng/ml; or about 312 ng/ml; or about 325 ng/ml; or about 350 ng/ml; orabout 375 ng/ml; or about 400 ng/ml; or about 425 ng/ml; or about 450ng/ml; or about 500 ng/ml. In some embodiments a solution as providedherein includes a mixture of antimicrobial agents. In some embodiments asolution as provided herein includes penicillin, streptomycin andAmphotericin B. In some embodiments a solution as provided hereinincludes 125 Units/ml penicillin, 125 mg/ml streptomycin, 312 ng/mlAmphotericin B. In some embodiments, the antimicrobial agent maycomprise at least 1, 2, or 3 member(s) selected from the groupconsisting of: penicillin, streptomycin, and amphotericin B. Theantimicrobial agent may comprise at most 3, 2, or 1 member(s) selectedfrom the group consisting of: penicillin, streptomycin, and amphotericinB. The antimicrobial agent may comprise a number of member(s) that iswithin a range defined by any two of the preceding values. In certainembodiments, a solution as provided herein may include one or more; ortwo or more; or three or more antimicrobials selected from the groupconsisting of Aminoglycosides, Amikacin, Gentamicin, Kanamycin,Neomycin, Netilmicin, Tobramycin, Paromomycin, Streptomycin,Spectinomycin(Bs), Ansamycins, Geldanamycin, Herbimycin, Rifaximin,Carbacephem, Loracarbef, Carbapenems, Ertapenem, Doripenem,Imipenem/Cilastatin, Meropenem, Cephalosporins, Cefadroxil, Cefazolin,Cephradine, Cephapirin, Cephalothin, Cefalexin, Cephalosporins,Cefaclor, Cefoxitin, Cefotetan, Cefamandole, Cefmetazole, Cefonicid,Loracarbef, Cefprozil, Cefuroxime, Cephalosporins, Cefixime, Cefdinir,Cefditoren, Cefoperazone, Cefotaxime, Cefpodoxime, Ceftazidime,Ceftibuten, Ceftizoxime, Moxalactam, Ceftriaxone, Cephalosporins,Cefepime, Cephalosporins (Fifth generation), Ceftaroline, fosamil,Ceftobiprole, Glycopeptides, Teicoplanin, Vancomycin, Telavancin,Dalbavancin, Oritavancin, Lincosamides(Bs), Clindamycin, Lincomycin,Lipopeptide, Daptomycin, urine Stabilur tablet, Macrolides(Bs),Azithromycin, Clarithromycin, Erythromycin, Roxithromycin Telithromycin,Spiramycin, Fidaxomicin, Monobactams, Aztreonam, Nitrofurans,Furazolidone, Nitrofurantoin(Bs), Oxazolidinones(Bs), Linezolid,Posizolid, Radezolid, Torezolid, Penicillins, Amoxicillin, Ampicillin,Azlocillin, Dicloxacillin, Flucloxacillin, Mezlocillin, Methicillin,Nafcillin, Oxacillin, Penicillin G, Penicillin V, Piperacillin,Penicillin G, Temocillin, Ticarcillin, Penicillin combinations,Amoxicillin/clavulanate, Ampicillin/sulbactam, Piperacillin/tazobactam,Ticarcillin/clavulanate, Polypeptides, Bacitracin, Colistin, PolymyxinB, Quinolones/Fluoroquinolones, Ciprofloxacin, Enoxacin, Gatifloxacin,Gemifloxacin, Levofloxacin, Lomefloxacin, Moxifloxacin, Nadifloxacin,Nalidixic acid, Norfloxacin, Ofloxacin, Trovafloxacin, Grepafloxacin,Sparfloxacin, Temafloxacin, Sulfonamides(Bs), Mafenide Sulfacetamide,Sulfadiazine, Silver sulfadiazine, Sulfadimethoxine, Sulfamethizole,Sulfamethoxazole, Sulfanilimide (archaic), Sulfasalazine, Sulfisoxazole,Trimethoprim-Sulfamethoxazole (Co-trimoxazole) (TMP-SMX),Sulfonamidochrysoidine (archaic), Tetracyclines(Bs), Demeclocycline,Doxycycline, Metacycline, Minocycline, Oxytetracycline, Tetracycline,Clofazimine, Dapsone, Capreomycin, Cycloserine, Ethambutol(Bs),Ethionamide, Isoniazid, Pyrazinamide, Rifampicin (Rifampin in US),Rifabutin, Rifapentine, Streptomycin, Others, Arsphenamine,Chloramphenicol(Bs), Fosfomycin, Fusidic acid, Metronidazole, Mupirocin,Platensimycin, Quinupristin/Dalfopristin, Thiamphenicol,Tigecycline(Bs), Tinidazole, and Trimethoprim(Bs). In certain otherembodiments, an antimicrobial of a solution as provided herein may oneor more siderophores selected from the group consisting ofAchromobactina, Acinetobactin, Acinetoferrin, Aerobactin, Aeruginicacid, Agrobactin, Agrobactin A, Albomycin, Alcaligin, Alterobactin A,Alterobactin A, Aminochelin, Amonabactin P693, Amonabactin P750,Amonabactin T732, Amonabactin T789, Amphibactin B, Amphibactin C,Amphibactin D, Amphibactin E, Amphibactin F, Amphibactin G, AmphibactinH, Amphibactin I, Amphibactin S, Amphibactin T, Amphi-enterobactin,Amphi-enterobactin C12-OH, Amycolachrome, Anachelin 1, Anachelin 2,Anguibactin, Aquachelin A, Aquachelin B, Aquachelin C, Aquachelin D,Aquachelin I, Aquachelin J, Arthrobactin, Asperchrome A, Asperchrome B1,Asperchrome B2, Asperchrome B3, Asperchrome C, Asperchrome D1,Asperchrome D2, Asperchrome D3, Asperchrome E, Asperchrome F1,Asperchrome F2, Asperchrome F3, Aspergillic acid, Avenic acid,Azotobactin, Azotobactin 87, Azotobactin D, Azotochelin, Azoverdin,Bacillibactin, Basidiochrome, Bisucaberin, Carboxymycobactin,Carboxymycobactin 1, Carboxymycobactin 2, Carboxymycobactin 3,Carboxymycobactin 4, Cepabactin, Chrysobactin, Citrate, Coelichelin,Coprogen, Coprogen B, Corynebactin, Deoxydistichonic acid,2′-Deoxymugineic acid, Deoxyschizokinen, Des(diserylglycyl)-ferrirhodin,Desacetylcoprogen, Deferoxamine Mesylate, Desferrioxamine A1A,Desferrioxamine A1B, Desferrioxamine A2, Desferrioxamine B,Desferrioxamine D1, Desferrioxamine D2, Desferrioxamine E,Desferrioxamine Et1, Desferrioxamine Et2, Desferrioxamine Et3,Desferrioxamine G1, Desferrioxamine G2A, Desferrioxamine G2B,Desferrioxamine G2C, Desferrioxamine H, Desferrioxamine N,Desferrioxamine P1, Desferrioxamine T1, Desferrioxamine T2,Desferrioxamine T3, Desferrioxamine T7, Desferrioxamine T8,Desferrioxamine Te1, Desferrioxamine Te2, Desferrioxamine Te3,Desferrioxamine X1, Desferrioxamine X2, Desferrioxamine X3,Desferrioxamine X4, Desferrithiocin, 2,3-Dihydroxybenzoylserine, Dimerumacid, Dimethylcoprogen, Dimethylneocoprogen I, Dimethyltriornicin,Distichonic acid, E,E-putrebactene, Enantio Rhizoferrin,Enantio-Pyochelin, Enterobactin, Enterochelin, E-putrebactene, ExochelinMN, Exochelin MS, Ferrichrome, Ferrichrome A, Ferrichrome C,Ferrichrysin, Ferricrocin, Ferrimycin A, Ferrirhodin, Ferrirubin,Ferrocin A, Fimsbactin A, Fimsbactin B, Fimsbactin C, Fimsbactin D,Fimsbactin E, Fimsbactin F, Fluvibactin, Formobactin, Fusarinine,Fusarinine A, Fusarinine B, Fusarinine C, Heterobactin A, HeterobactinB, Hydroxycopropen, Hydroxyisoneocoprogen I, 3-Hydroxymugineic acid,Hydroxy-neocoprogen I, Isoneocoprogen I, Isopyoverdin 10.7, Isopyoverdin6.7, Isopyoverdin 7.13, Isopyoverdin 90-33, Isopyoverdin 90-44,Isopyoverdin BTP1, Isotriornicin, Itoic acid, Loihichelin A, LoihichelinB, Loihichelin C, Loihichelin D, Loihichelin E, Loihichelin F,Maduraferrin, Malonichrome, Marinobactin, Marinobactin, Marinobactin,Marinobactin, Marinobactin, Marinobactin, Micacocidin, Moanachelins,Moanachelins, Moanachelins, Moanachelins, Moanachelins,Monoglucosylated, Mugineic, Mycobactin A, Mycobactin Av, Mycobactin F,Mycobactin H, Mycobactin J, Mycobactin M, Mycobactin N, Mycobactin NA,Mycobactin P, Mycobactin R, Mycobactin S, Mycobactin T, Myxochelin,Nannochelin A, Nannochelin B, Nannochelin C, Neocoprogen I, NeocoprogenII, Neurosporin, Nocobactin, Ochrobactin A, Ochrobactin B, OchrobactinC, Ornibactin-C4, Ornibactin-C6, Ornibactin-C8, Omicorrugatin,Palmitoylcoprogen, Parabactin, Parabactin A, Petrobactin, Petrobactindisulphonate, Petrobactin sulphonate, Pistillarin, Protochelin,Pseudoalterobactin A, Pseudoalterobactin B, Pseudobactin, Pseudobactin589A, Putrebactin, Pyochelin, Pyoverdin 1, Pyoverdin 10.1, Pyoverdin10.10, Pyoverdin 10.2, Pyoverdin 10.3, Pyoverdin 10.4, Pyoverdin 10.5,Pyoverdin 10.6, Pyoverdin 10.8, Pyoverdin 10.9, Pyoverdin 11.1,Pyoverdin 11.2, Pyoverdin 11370, Pyoverdin 12, Pyoverdin 12.1, Pyoverdin12.2, Pyoverdin 13525, Pyoverdin 1547, Pyoverdin 17400, Pyoverdin 18-1,Pyoverdin 19310, Pyoverdin 2192, Pyoverdin 2392, Pyoverdin 2461,Pyoverdin 2798, Pyoverdin 51W, Pyoverdin 6.1, Pyoverdin 6.2, Pyoverdin6.3, Pyoverdin 6.4, Pyoverdin 6.5, Pyoverdin 6.6, Pyoverdin 6.8,Pyoverdin 7.1, Pyoverdin 7.10, Pyoverdin 7.11, Pyoverdin 7.12, Pyoverdin7.14, Pyoverdin 7.15, Pyoverdin 7.16, Pyoverdin 7.17, Pyoverdin 7.18,Pyoverdin 7.19, Pyoverdin 7.2, Pyoverdin 7.3, Pyoverdin 7.4, Pyoverdin7.5, Pyoverdin 7.6, Pyoverdin 7.7, Pyoverdin 7.8, Pyoverdin 7.9,Pyoverdin 8.1, Pyoverdin 8.2, Pyoverdin 8.3, Pyoverdin 8.4, Pyoverdin8.5, Pyoverdin 8.6, Pyoverdin 8.7, Pyoverdin 8.8, Pyoverdin 8.9,Pyoverdin 9.1, Pyoverdin 9.10, Pyoverdin 9.11, Pyoverdin 9.12, Pyoverdin9.2, Pyoverdin 9.3, Pyoverdin 9.4, Pyoverdin 9.5, Pyoverdin 9.6,Pyoverdin 9.7, Pyoverdin 9.8, Pyoverdin 9.9, Pyoverdin 90-51, Pyoverdin95-275, Pyoverdin 96-312, Pyoverdin 96-318, Pyoverdin 9AW, PyoverdinA214, Pyoverdin BTP2, Pyoverdin C, Pyoverdin CHAO, Pyoverdin D-TR133,Pyoverdin E, Pyoverdin G, Pyoverdin GM, Pyoverdin I-III, Pyoverdin P19,Pyoverdin Pau, Pyoverdin PL8, Pyoverdin PVD, Pyoverdin R′, PyoverdinThai, Pyoverdin TII, Pyridoxatin, Quinolobactin, Rhizobactin,Rhizobactin 1021, Rhizoferrin, Rhizoferrin analogues, Rhodotrulic acid,Sake Colorant A, Salmochelin S1, Salmochelin S2, Salmochelin S4,Salmochelin SX, Salmycin A, Schizokinen, Serratiochelin, Siderochelin A,Snychobactin A, Snychobactin B, Snychobactin C, Staphyloferrin A,Staphyloferrin B, Taiwachelin, Tetraglycine ferrichrome, Thiazostatin,Triacetylfusarine, Triornicin, Vibriobactin, Vibrioferrin, Vicibactin,Vulnibactin, and Yersiniabactin.

In some embodiments, a solution of the disclosure includes a chelatingagent, a detergent, a salt, a cationic polymer, a pH buffering agent, acrowding agent, paramagnetic beads and an antimicrobial; wherein thechelating agent is present in an amount between either 25-750 uM or10-100 mM in the solution; wherein the detergent is present in an amountbetween 0.1-1.0% weight/volume of the solution; wherein the salt ispresent in an amount between 1-2M in the solution; wherein the cationicpolymer is present in an amount between 10-100 mg/L in the solution; andwherein the crowding agent is present in an amount between 10-20% of thesolution. In some similar embodiments, a solution of the disclosureincludes a chelating agent, a detergent, a salt, a cationic polymer, apH buffering agent, a crowding agent, paramagnetic beads and anantimicrobial; wherein the chelating agent is present in an amountbetween either 25-750 μM or 10-100 mM in the solution; wherein thedetergent is present in an amount between 0.1-1.0% weight/volume of thesolution; wherein the salt is present in an amount between 1-2M in thesolution; wherein the cationic polymer is present in an amount between10-100 mg/L in the solution; and wherein the crowding agent is presentin an amount between 10-20% of the solution; and wherein the solutionfurther includes paramagnetic beads and an antimicrobial.

In some embodiments a solution of the present disclosure includesparamagnetic beads. As used herein the term “paramagnetic beads” meansbeads that have an affinity for nucleic acid and can be used to extractnucleic acid from a sample. In some embodiments, the paramagnetic beadsare 10 nm-10 μm. In some embodiments, the paramagnetic beads are 100nm-10 μm; or 500 nm-5 μm; or 500 nm-2 μm; or 500 nm-1.5 μm; or 750nm-1.25 μm; or about 500 nm; or about 600 nm; or about 700 nm; or about750 nm; or about 800 nm; or about 900 nm; or about 1p m; or about 1.1μm; or about 1.2 μm; or about 1.25 μm; or about 1.3 μm; or about 1.4 μm;or about 1.5 μm. In some embodiments, the paramagnetic beads are 1-100nm; or 10-50 nm; or 10-20 nm; or 20-30 nm; or 30-40 nm; or 40-50 nm; or5-25 nm; or 15-35 nm; or 20-40 nm. Bead sizes stated herein areexpressed as average diameter size. In certain embodiments, theparamagnetic beads comprise an iron oxide such as magnetite (Fe3O4)which give the beads superparamagnetic properties. In some embodiments;the paramagnetic beads include 30-70% magnetite; or 40-60% magnetite; or30-50% magnetite; or 35-45% magnetite; or 40-50% magnetite; or 50-70%magnetite; or 55-65% magnetite; or about 30% magnetite; or about 35%magnetite; or about 40% magnetite; or about 45% magnetite; or about 50%magnetite; or about 55% magnetite; or about 60% magnetite; or about 65%magnetite; or about 70% magnetite. Beads with superparamagneticproperties exhibit magnetic activity only in the presence of an externalmagnetic field, enabling the beads to be used without clumping withoutan external magnetic field and then be separated from the solution whenexposed to an external magnetic field. In certain embodiments, In someembodiments of the compositions and methods provided herein the beadsare present in a solution (such as a preservation/extraction solution asdescribed) in an amount that is 1 mg/L-10 g/L; or 5 mg/L-5 g/L; or 25mg/L-2.5 g/L; or 50 mg/L-1 g/L; or 50 mg/L-500 mg/L; or 50 mg/L-200mg/L; or 50 mg/L-150 mg/L; or 75 mg/L-125 mg/L; or about 1 mg/L; orabout 10 mg/L; or about 50 mg/L; or about 60 mg/L; or about 70 mg/L; orabout 75 mg/L; or about 80 mg/L; or about 90 mg/L; or about 100 mg/L; orabout 110 mg/L; or about 120 mg/L; or about 125 mg/L; or about 130 mg/L;or about 140 mg/L; or about 150 mg/L; or about 175 mg/L; or about 200mg/L; or about 250 mg/L; or about 500 mg/L; or about 750 mg/L; or about1.0 g/L; or about 2.5 g/L; or about 5 g/L; or about 7.5 g/L; or about 10g/L. In many embodiments the beads comprise or are coated with asubstance having an affinity for nucleic acids, for example carboxylatemodified beads that can hybridize with nucleic acid for direct capture,amine-blocked beads, oligo(dT) beads that hybridize mRNA with poly-Atails, streptavidin beads, silica based or coated bead composition ormethod of any one of the preceding claims wherein solutions used do notincludes that reversibly bind nucleic acids. In some embodiments theparamagnetic beads are carboxylate modified (or carboxylate conjugated).In some embodiments the paramagnetic beads are silica coated. In someembodiments the paramagnetic beads are functional group modified (e.g.,carboxy, amine, or other functional groups). In some embodiments theparamagnetic beads are amine-modified. In some embodiments, theparamagnetic beads are ligand-modified. In various embodiments abiological sample as described herein is added to a solution of thedisclosure that includes paramagnetic beads, and nucleic acid from thebiological sample binds to the beads while in the solution. The solutionis then exposed to a magnetic field to attract the beads to a specificlocation such as the edge of a tube containing the solution, allowingthe solution to be washed and the sample nucleic acids to be extractedand isolated from the solution. In many embodiments solutions of thedisclosure having the magnetic beads and associated extraction/isolationmethods are amenable to high-throughput nucleic acid processing andanalysis. Some examples of compositions and methods involvingparamagnetic beads that can be useful with the compositions and methodsdescribed herein can be found in U.S. Pat. No. 5,705,628; He et al,Nature Scientific Reports 7:45199, DOI:10.1038, srep45199 (2017); andBerensmeier, Appl Micorbiol Biotechnol. 2006, 73(3):495-504, herebyincorporated by reference in their entirety.

In some embodiments, a solution is provided that includes a chelatingagent, a detergent, a salt, a cationic polymer, a pH buffering agent, acrowding agent, paramagnetic beads and an antimicrobial, wherein thechelating agent is one or more selected from the group consisting ofenterobactin, deferasirox (DFS), deferiprone (DFP), deferoxaminemesylate, EDTA, and EGTA; wherein the detergent includes one or moreselected from the group consisting of cholate, deoxycholate, sodiumdodecyl sulfate, sarkosyl, DDM, digitonin, NP-40, Triton X-100, Tween20, and Tween 80; wherein the salt is sodium chloride; wherein thecationic polymer is one or more selected from the group consisting ofPoly-L-Arginine, Poly-D-Lysine, and Poly-L-Lysine; wherein the crowdingagent includes one or more selected from the group consisting ofEthanol, Isopropanol, PEG 4000, PEG6000, and PEG8000; and wherein theantimicrobial is one or more selected from a group consisting ofpenicillin, streptomycin, Amphotericin B, and a urine stabilur tablet.

In some embodiments, a solution of the present disclosure includes achelating agent, a detergent, a salt, a cationic polymer, a pH bufferingagent, a crowding agent, paramagnetic beads and an antimicrobial;wherein the chelating agent is one or more selected from the groupconsisting of enterobactin, deferasirox (DFS), deferiprone (DFP),deferoxamine mesylate, EDTA, and EGTA, wherein the chelating agent ispresent in an amount between either 25-750 μM or 10-100 mM in thesolution; wherein the detergent comprises one or more selected from thegroup consisting of Cholate, Deoxycholate, Sodium Dodecyl Sulfate,Sarkosyl, DDM, Digitonin, NP-40, Triton X-100, Tween 20, and Tween 80,and wherein the detergent is present in an amount between 0.1-1.0% ofthe solution; wherein the salt is sodium chloride, and wherein the saltis present in an amount of 1.5M in solution; wherein the cationicpolymer comprises one or more selected from the group consisting ofPoly-L-Arginine, Poly-D-Lysine, and Poly-L-Lysine, and wherein thecationic polymer is present in an amount between 10-100 mg/L in thesolution; wherein the crowding agent comprises on or more selected fromthe group consisting of Ethanol, Isopropanol, PEG 4000, PEG6000, andPEG8000, and wherein the crowding agent is present in an amount between10-20% of the solution; and wherein the antimicrobial is selected from agroup consisting of penicillin, streptomycin, Amphotericin B, and aurine stabilur tablet.

In some embodiments, provided is a solution of any of the embodimentsprovided herein wherein nucleic acid is stable in the solution for atleast seven days at room temperature. In some embodiments, provided is asolution of any of the embodiments provided herein wherein nucleic acidis stable in the solution for at least one day, or two days, or threedays, or four days, or five days, or six days, or seven days, or twoweeks, or three weeks, or four weeks or five weeks, or six weeks, orseven weeks, or three months, or four months, or five months, or sixmonths, or eight months, or twelve months, or two years, or three years,or four years at room temperature. The term “stable” as used herein withregard to nucleic acid means nucleic acid that serves as a viabletemplate for nucleic acid analysis. Wherein types of nucleic acidanalysis could include but are not limited to: polymerase chain reaction(PCR) amplification, nucleic acid sequencing, isothermal amplification,and hybridization pull down. Stability of nucleic acid can be determinedby any of many ways well known in the art. For example, in someembodiments nucleic acid may be considered stable if (1) the moleculeremains intact, as assessed by gel/capillary electrophoresis, (2) thetemplate portion of the molecule remains intact, as assessed by PCR, (3)sequence integrity is intact, as assessed by nucleic acid sequencing,after a specified period of time. In some embodiments, nucleic acidstability may be determined 6 hours, 12 hours, 18 hours, 24 hours, twodays, three days, four days, five days, six days, seven days, eightdays, nine days, ten days, two weeks, three weeks, one month, twomonths, three months, four months, five months, six months, one year,two years or more after the nucleic acid is added to a solution, such asa solution as contemplated herein.

In some embodiments of the solutions provided herein, the solution is acollection/preservation, and extraction solution for preserving nucleicacids from a biological sample. In some embodiments, a solution asprovided herein is a preservation, and extraction solution forpreserving nucleic acids from a biological sample, wherein the nucleicacid is DNA. In some embodiments, a solution as provided herein is apreservation, and extraction solution for preserving nucleic acids froma biological sample, wherein the nucleic acid is RNA. In someembodiments, a solution as provided herein is a preservation, andextraction solution for preserving nucleic acids from a biologicalsample, wherein the nucleic acids are from a biological sample to thathas, is suspected of having, or is at risk to have, nucleic acid from apathogen. In some embodiments, a solution as provided herein is apreservation, and extraction solution for preserving nucleic acids froma biological sample, wherein the nucleic acids are from a biologicalsample to that has, is suspected of having, or is at risk to have,nucleic acid from a pathogen; wherein the pathogen is one or moreselected from the group consisting of (1) viruses of families including,but not limited to, Adenoviridae, Herpesviridae, Papillomaviridae,Polyomarviridae, Poxviridae, Parvoviridae, Reoviridae, Astroviridae,Caliciviridae, Coronaviridae, Flaviviridae, Hepeviridae, Matonaviridae,Picornaviridae, Arenaviridae, Bunyarviridae, Filoviridae,Orthomyxoviridae, Paramyxoviridae, Pneumoviridae, Rhabdoviridae,Retroviridae, and Hepadnaviridae, (2) bacteria of genera including, butnot limited to, Bacillus, Bartonella, Bordetella, Borrelia, Brucella,Campylobacter, Chlamydia, Chlamydophila, Clostridium, Corynebacterium,Enterococcus, Escherichia, Francisella, Haemophilus, Helicobacter,Legionella, Leptospira, Listeria, Mycobacterium, Mycoplasma, Neisseria,Pseudomonas, Rickettsia, Salmonella, Shigella, Staphylococcus,Streptococcus, Treponema, Ureaplasma, Vibrio, and Yersinia, (3) fungi ofgenera including, but not limited to, Aspergillus, Candida,Cryptococcus, Histoplasma, Pneumocystis, and Stachybotrys, and (4)protozoa and algae including, but not limited to, Prototheca wickerhami,Plasmodium, Entamoeba, Giardia, Trypanosoma brucei, Toxoplasma gondii,Acanthamoeba, Leishmania, Babesia, Balamuthia mandrillaris,Cryptosporidium, Cyclospora, and Naegleria fowler. In some embodimentsof the solutions of the disclosure, nucleic acid is stable 6 hours, 12hours, 18 hours, 24 hours, two days, three days, four days, five days,six days, seven days, eight days, nine days, ten days, two weeks, threeweeks, one month, two months, three months, four months, five months,six months, one year, two years or more after the nucleic acid is addedto the solution.

As used herein the term “biological sample” is any sample collected froma biological source or that includes, or may include, any matter from abiological source. In some embodiments a biological sample as usedherein is any sample that includes, or may include, nucleic acid. Insome embodiments, a biological sample is a sample collected from ananimal. In some embodiments, a biological sample is a sample collectedfrom a human. In some embodiments a biological sample is a samplecollected from a plant. In some embodiments a biological sample mayinclude one or more selected from the group consisting of urine, blood,plasma, serum, mucus, saliva, ophthalmic liquid, feces, cells, andtissue. In certain embodiments, a biological sample is any sample thatis suspected of having, or may have, a pathogen. In certain embodiments,a biological sample is any sample that is suspected of having, or mayhave, nucleic acid of a pathogen. In certain embodiments, a biologicalsample is any sample that is suspected of having, or may have, nucleicacid. In some embodiments, a biological sample is any sample that issuspected of having, or may have, nucleic acid, wherein there is aninterest or desire in detecting or analyzing the nucleic acid. In someembodiments, a nucleic acid of the disclosure is RNA. In someembodiments, a nucleic acid of the disclosure is DNA. In someembodiments, the biological sample is from animal effluent or sewage;for example, in some embodiments the biological sample is from sewagefrom a building and is useful to determine if an individual that hadbeen in a building may be infected with a pathogen. In certainembodiments a biological sample may be a food product. In someembodiments, a biological sample may be a food product that is suspectedof having, or may have, nucleic acid. In some embodiments, a biologicalsample may be a food product that is suspected of having, or may have, apathogen. In some embodiments, a biological sample may be a food productthat is suspected of having, or may have, nucleic acid from a pathogen.In certain embodiments, a food product as used herein is any productthat is intended for human consumption. In certain embodiments, a foodproduct as used herein is may be a beverage, water, produce, fruit,vegetable, grain, cereal, processed food, bread, cracker, cookie, meat,processed meat and the like. In some embodiments, a biological samplemay be from livestock and/or poultry. In some embodiments a biologicalsample is from a commodity such as meat, eggs, milk, fur, leather, orwool. In some embodiments the biological sample is from effluent and/oranimal waste from a farm with domesticated animals such as livestock orpoultry. In some embodiments, a biological sample may be taken from aslaughter house. In some embodiments, a biological sample may be takenfrom a carcass from a slaughter house. In some embodiments, a biologicalsample may be from chicken carcass wash. In some embodiments, abiological sample may be taken livestock carcass wash. In someembodiments, a biological sample may be from a carcass of an animal thatdied, or exhibited weakness or illness prior to slaughter. In someembodiments, a biological sample may be a sample from an environmentalsource that is suspected of having, or may have, nucleic acid. In someembodiments, a biological sample may be a sample from an environmentalsource that is suspected of having, or may have, a pathogen. In someembodiments, a biological sample may be a sample from an environmentalsource that is suspected of having, or may have, nucleic acid from apathogen. In some embodiments, a biological sample from an environmentalsource is any sample collected from the environment. In someembodiments, a sample from an environmental source is a water sample, awater sample from an ocean, a water sample from a bay or estuary, awater sample from a river, a water sample from a swamp, a water samplefrom a lake, a water sample from a swimming pool, a soil sample, and thelike. In some embodiments as used herein a biological sample iscollected by nasal swab. In some embodiments as used herein a biologicalsample is collected by throat swab. In some embodiments as used herein abiological sample is collected by nasopharyngeal swab. In someembodiments as used herein a biological sample is collected by vaginalswab. In some embodiments as used herein a biological sample iscollected by penile meatal swab. In some embodiments as used herein abiological sample is collected by rectal swab. In some embodiments asused herein a biological sample is collected by urogenital swab ofvagina, cervix, discharge, aspirated endocervical, endometrial, semen,prostatic fluid, or urethral discharge. In some embodiments a biologicalsample includes, or may include, nucleic acids. In some embodiments abiological sample used herein includes DNA. In some embodiments abiological sample used herein includes RNA. A biological sample ofcertain embodiments provided herein may be a biological sample suspectedof having nucleic acids from a pathogen. In certain embodiments, abiological sample is collected from a subject suspected to be infectedwith the SARS-CoV2 virus. In certain embodiments, a biological sample iscollected from a subject desiring to be tested for infection with theSARS-CoV2 virus.

In a second aspect a kit is provided, wherein the kit includes asolution of any of the embodiments provided herein. In some embodimentsthe kit includes one or more receptacles that have a solution asprovided herein. In certain embodiments of a kit, the solution asprovided herein in a multi-well plate. In some embodiments of a kit, thesolution and plate are integrated into a testing system which includesother reagents enabling the detection or measurement of specific nucleicacid sequences. In some embodiments, the kit includes a solution asprovided herein in a tube. In certain embodiments, the tube has asolution as contemplated herein and is configured to accept a biologicalsample into the solution. In certain embodiments, the tube has asolution as contemplated herein and is configured to accept a biologicalsample from a sampling swab into the solution. In certain embodiments,the kit contains a tube with a solution as described herein and asampling device suitable for collecting a biological sample from asubject. In some embodiments, the tube is configured to be suitable forhigh throughput nucleic acid extraction and evaluation. In someembodiments a tube, as used herein, is a well in a plate such as a 48 or96 well plate. In some embodiments, a kit as provided herein isconfigured to be suitable for high throughput nucleic acid extractionand evaluation. In various embodiments, the kit is configured to be usedin any embodiments of the methods provided herein. In certainembodiments, the kit is used in any embodiments of the methods providedherein.

In various aspects and embodiments of the compositions and methodsprovided herein, nucleic acid from a sample (such as a biologicalsample) is detected and/or analyzed. For example, some embodimentsinvolve evaluating nucleic acid for the presence or absence of a geneticmarker or for nucleic acid associated with a pathogen, or a variant of apathogen. In some embodiments, the nucleic acid and/or detection mayinvolve nucleic acid amplification methods, PCR, RT-PCR, quantitativePCR, RFLP analysis, nucleic acid sequencing, next-generation sequencing,nucleic acid hybridization analyses, northern blotting, southernblotting, or the like. In some embodiments, the nucleic acid detectionand/or analysis includes nucleic acid amplification. Nucleic acid can beamplified by one of the alternative methods for amplification well knownin the art, which include for example: polymerase chain reaction (PCR);multiplex PCR that allows the simultaneous amplification of several DNAsequences; multiplex ligation-dependent probe amplification (MLPA) forthe amplification of multiple targets using a single pair of primers;quantitative PCR (qPCR), which measures and quantify the amplificationin real time; ligation chain reaction (LCR) that uses primers coveringthe entire sequence to amplify, thereby preventing the amplification ofsequences with a mutation; rolling circle amplification (RCA), whereinthe two ends of the sequences are joined by a ligase prior to theamplification of the circular DNA; helicase dependent amplification(HDA) which relies on a helicase for the separation of the doublestranded DNA; loop mediated isothermal amplification (LAMP) whichemploys a DNA polymerase with high strand displacement activity; thenucleic acid sequence based amplification, specifically designed for RNAtargets; strand displacement amplification (SDA) which relies on astrand-displacing DNA polymerase, to initiate replication at nickscreated by a strand-limited restriction endonuclease or nicking enzymeat a site contained in a primer; the multiple displacement amplification(MDA), based on the use of the highly processive and strand displacingDNA polymerase from the bacteriophage Ø29; the Xmap® technology ofLuminex that allows the simultaneous analysis of up to 500 bioassaysthrough the reading of biological test on the surface of microscopicpolystyrene bead. In certain embodiments the analysis and/or detectionof nucleic acid may involve gel electrophoresis using agarose orpolyacrylamide gel; ethidium bromide staining (a DNA intercalant),labeled probes (radioactive or non-radioactive labels, southernblotting), labeled deoxyribonucleotides (for the direct incorporation ofradioactive or non-radioactive labels) or silver staining for the directvisualization of amplified PCR products; restriction endonucleasedigestion; high-performance liquid chromatography (HPLC); dot blots;hybridization of amplified DNA on specific labeled probes (radioactiveor non-radioactive labels); high-pressure liquid chromatography usingultraviolet detection; electro-chemiluminescence coupled withvoltage-initiated chemical reaction/photon detection; direct sequencingusing radioactive or fluorescently labeled deoxyribonucleotides for thedetermination of the precise order of nucleotides with a DNA fragment ofinterest; oligo ligation assay (OLA); PCR; qPCR; DNA sequencing,fluorescence, gel electrophoresis, magnetic beads, allele specificprimer extension (ASPE) and/or direct hybridization. Examples of nucleicacid analysis may include sequencing. Sequencing may be by any methodknown in the art. DNA sequencing techniques include classic dideoxysequencing reactions (Sanger method) using labeled terminators orprimers and gel separation in slab or capillary, and next generationsequencing methods such as sequencing by synthesis using reversiblyterminated labeled nucleotides, pyrosequencing, 454 sequencing,Illumina/Solexa sequencing, direct detection nanopore based sequencingsuch as Oxford Nanopore, Single Molecule Real-Time Sequencing such asPacBio, allele specific hybridization to a library of labeledoligonucleotide probes, sequencing by synthesis using allele specifichybridization to a library of labeled clones that is followed byligation, real time monitoring of the incorporation of labelednucleotides during a polymerization step, polony sequencing, and SOLiDsequencing. Separated molecules may be sequenced by sequential or singleextension reactions using polymerases or ligases as well as by single orsequential differential hybridizations with libraries of probes.

As used herein, a kit or tube configured to be suitable for highthroughput nucleic acid extraction and evaluation includes features suchas: a tube amenable to mechanical capping/de-capping, and/or amendableto high throughput accessioning through use of barcode labels, and/or atube configured for application of a magnetic field to enable theimmobilization of paramagnetic nucleic acid binding beads and subsequentwashing or buffer exchange on the beads. In some embodiments “highthroughput” may refer to a system or kit that involves robotic handlingof the samples and or performance of one or more steps of the methodscontemplated herein. In some embodiments “high throughput” may refer toa system or kit that may enable extraction and analysis of 20-200samples per day, or 200-1,000 samples per day, 500-10,000 samples perday, 5,000-50,000 samples per day, 25,000-100,000 samples per day,50,000-500,000 samples per day. A non-limiting list of exemplaryhigh-throughput systems that could be used with the compositions andmethods provided herein include Tecan Freedom Evo, Hamilton STAR, QiagenQIAsymphony, Chemagic MSM or the King Fisher Flex Liquid HandlingSystem.

As used herein, washing, or a wash solution, or wash buffer, includesexposing beads (possibly having nucleic acid bound to the beads) to asolution removes proteins, salts, and other contaminants but leaves thenucleic acid bound to the beads. In many embodiments, a wash solution orwash buffer is alcohol based.

In a third aspect, a method is provided that involves providing asolution or kit (including a kit that includes a tube with a solution ofthe disclosure) of any of the aspects or embodiments of the disclosureand contacting a biological sample that includes nucleic acid with thesolution. In some embodiments, the method includes providing a solutionor kit of any of the aspects and embodiments of the disclosure,contacting a biologic sample that includes nucleic acid with thesolution; and subsequently evaluating the nucleic acid for the presenceor absence of a genetic marker or for nucleic acid of a pathogen. Insome embodiments of the methods of the disclosure, the method includesproviding a solution or kit as described herein; contacting a biologicalsample that includes nucleic acid with the solution; and evaluating thenucleic acid for the presence or absence of a genetic marker or apathogen without use of a second extraction solution.

In one embodiment, the method involves providing a tube that includes asolution of the instant disclosure with paramagnetic beads having anaffinity for nucleic acid; wherein (1) a biological sample that has, ormay have, nucleic acid from a pathogen is contacted with the solutionsuch that the nucleic acid from the biological sample can bind to theparamagnetic beads, (2) the tube is exposed to a magnetic field toisolate the beads from the solution, (3) the beads are washed andnucleic acid is subsequently eluted, and (4) the nucleic acid that wasbound to the beads is analyzed. In one embodiment, the method involvesproviding a tube that includes a solution of the instant disclosure withparamagnetic beads having an affinity for nucleic acid; wherein (1) abiological sample that has, or may have, nucleic acid from a pathogen iscontacted with the solution such that the nucleic acid from thebiological sample can bind to the paramagnetic beads, (2) the tube isexposed to a magnetic field to isolate the beads from the solution, (3)the beads are washed and nucleic acid is subsequently eluted, and (4)the nucleic acid that was bound to the beads is analyzed. In someembodiments, the method involves providing a tube that includes asolution of the instant disclosure with paramagnetic beads having anaffinity for nucleic acid; wherein (1) a biological sample that has, ormay have, nucleic acid from a pathogen is contacted with the solutionsuch that the nucleic acid from the biological sample can bind to theparamagnetic beads, (2) the tube is exposed to a magnetic field toisolate the beads from the solution, (3) the beads are washed, and (4)the nucleic acid that was bound to the beads is analyzed for thepresence or absence of pathogenic nucleic acid. In one embodiment, themethod involves providing a tube that includes a solution of the instantdisclosure with paramagnetic beads having an affinity for nucleic acid;wherein (1) a biological sample that has, or may have, nucleic acid froma pathogen is contacted with the solution such that the nucleic acidfrom the biological sample can bind to the paramagnetic beads, (2) thetube is exposed to a magnetic field to isolate the beads from thesolution, (3) the beads are washed and nucleic acid is subsequentlyeluted, and (4) the nucleic acid that was bound to the beads is analyzedfor the presence or absence of pathogenic nucleic acid. In oneembodiment, the methods provided herein involve providing a tube thatincludes a solution of the instant disclosure with paramagnetic beadshaving an affinity for nucleic acid; wherein (1) a biological samplethat has, or may have, nucleic acid from a pathogen is contacted withthe solution such that the nucleic acid from the biological sample canbind to the paramagnetic beads, (2) the tube is exposed to a magneticfield to isolate the beads from the solution, (3) the beads are washedand nucleic acid is subsequently eluted, and (4) the nucleic acid thatwas bound to the beads is analyzed for the presence or absence ofpathogenic nucleic acid; wherein steps 2, 3 and 4 are performed withoutthe use of a nucleic acid extraction solution other than the solution ofstep 1. In certain embodiments of the methods provided herein, asidefrom than the initial preservation/extraction solution as disclosedherein, no additional extraction solution is used in the methods thatincludes a detergent. In certain embodiments of the methods providedherein, aside from than the initial preservation/extraction solution asdisclosed herein, no additional extraction solution is used in themethods that includes a detergent. In certain embodiments of the methodsprovided herein, aside from than the initial preservation/extractionsolution as disclosed herein, no additional extraction solution is usedin the methods that includes a detergent or any of the following:guanidine (such a guanidine salt, for example, guanidine thiocyanate,guanidine isothiocyanate, guanidine HCl, thiocyanic acid withguanidine), thiocyanate, sodium iodide, urea, an alkaline solution, oran enzyme such as, for example, proteinase K, trypsin, dispase,collagenase, cellulase, chitinase, lysozyme, lipase, zymolase, orliticase. In some embodiments the methods provided herein do not involvea lysis/extraction that involves a physical method such as one or moreof freezing and grinding, exposure to a temperature change (for examplea temperature change of more than 10° C.; or 20° C., or 25° C., or 30°C., or 40° C.; or 50° C.; or 60° C.; or 70° C.; or 80° C.; or 90° C.; or100° C.; or 125° C.; or more), or exposure to high-intensity sound waves(sonication), or exposure to changes in pressure.

In many current standard nucleic acid collection, extraction andanalysis methods and systems do not extract or concentrate the entiretyof the sample, rather typically take a small percentage of the totalsample for extraction and analysis. In samples with low amounts ofnucleic acid or pathogen, these sampling and sequential dilution stepscan result in loss of nucleic acid material thus impairing the abilityto successfully analyze the nucleic acid and increasing false negativeresults.

Most of such standard methods involve adding (contacting) a biologicalsample with a solution, and removing an aliquot of the solution havingthe biological sample for further nucleic acid evaluation; thusresulting in only a portion (often 10% or less) of the nucleic acid ofthe original biological sample being subjected to the nucleic acidanalysis. This can result in lower sensitivity of the nucleic acidevaluation, and in the case of tests to detect presence of nucleic acid(eg nucleic acid of a pathogen) the lower sensitivity can result infalse negative results. In certain embodiments of the presentdisclosure, by combining collection, preservation and/or extractioncomponents (in some embodiments including paramagnetic beads) into asingle solution that is contacted with the biological sample, all, ormost, of the solution (and all or most of the nucleic acid from thebiological solution) can be subjected to the nucleic acidanalysis-thereby increasing the sensitivity and accuracy of the test orevaluation. For example, typical automation enabled RNA extraction kitson the market today may process a maximum of 300 microliters of solutionper extraction. Due to RNA extraction kit shortage many protocols (CDC)and labs extract only 100 μl of starting transport media, swabs areroutinely placed in 2-3 ml of transport solution, resulting in 1/20th-1/30th of an initial sample extracted. For routine silica columnextraction kits larger elution volumes are required, so again accordingto CDC protocols a sample is eluted in 100 μl final volume, of whichonly 5 μl is placed into a testing reaction (another 20-fold dilution).In total between small volume extraction ( 1/30th) and large volumeelution ( 1/20th) total dilution can be in aggregate up to 1/600th of asample volume which is finally analyzed. In certain embodiments of themethods disclosed herein, by extracting the entire sample transportmedia (all material from the swab) using acollection/preservation/extraction solution as described herein, thefirst source of dilution can be avoided. In the final elution step ofsome of the methods of the disclosure, paramagnetic beads can be elutedefficiently in smaller volumes than traditional silica columns (30-50 μlas opposed to 100 μl), further minimizing dilution of the sample andimproving testing sensitivity. Accordingly, in one aspect a method isprovided wherein the method includes providing a solution of any one ofthe preceding embodiments having paramagnetic beads, wherein (1) abiological sample that has, or may have, nucleic acid from a pathogen iscontacted with the solution such that the nucleic acid from thebiological sample can bind to the paramagnetic beads, (2) the beads areisolated from the solution by one or more of exposure to a magneticfield, centrifugation or filtration, (3) the beads are washed andnucleic acid is subsequently eluted, and (4) the nucleic acid that wasbound to the beads is analyzed for the presence or absence of pathogenicnucleic acid; wherein at least 30%; or at least 40%; or at least 50%; orat least 60%; or at least 70%; or at least 75%; or at least 80%; or atleast 85%; or at least 90%; or at least 95% of the solution of step (1)that was contacted with the biological sample is used in step (2). Inanother aspect, a method is provided wherein the method includesproviding a solution of any one of the preceding embodiments havingparamagnetic beads, wherein (1) a biological sample that has, or mayhave, nucleic acid from a pathogen is contacted with the solution suchthat the nucleic acid from the biological sample can bind to theparamagnetic beads, (2) the beads are isolated from the solution by oneor more of exposure to a magnetic field, centrifugation or filtration,(3) the beads are washed and nucleic acid is subsequently eluted, and(4) the nucleic acid that was bound to the beads is analyzed for thepresence or absence of pathogenic nucleic acid; wherein at least 30%; orat least 40%; or at least 50%; or at least 60%; or at least 70%; or atleast 75%; or at least 80%; or at least 85%; or at least 90%; or atleast 95% of the total nucleic of the original biological sample isstill present after step (2). In yet another aspect, a method isprovided wherein the method includes providing a solution of any one ofthe preceding embodiments; wherein the solution is contacted with abiological sample and wherein at least 30%; or at least 40%; or at least50%; or at least 60%; or at least 70%; or at least 75%; or at least 80%;or at least 85%; or at least 90%; or at least 95% of the nucleic acidpresent in the biological sample is subjected to nucleic acid analysis.

In some embodiments of any of the methods as provided herein, theparamagnetic beads (or any other beads used to bind nucleic acid) areisolated from the solution by centrifugation, filtration or the like. Insome embodiments of any of the methods as provided herein, theparamagnetic beads (or any other beads used to bind nucleic acid) areisolated from the solution by centrifugation, filtration or the like andare not exposed to a magnetic field.

In certain embodiments, the methods involve providing a tube thatincludes a solution beads of the instant disclosure with paramagneticbeads having an affinity for nucleic acid; wherein (1) a biologicalsample that has, or may have, nucleic acid from a pathogen is contactedwith the solution such that the nucleic acid from the biological samplecan bind to the paramagnetic beads, (2) the tube is exposed to amagnetic field to isolate the beads from the solution, (3) the beads arewashed, and (4) the nucleic acid that was bound to the beads is analyzedfor the presence or absence of pathogenic nucleic acid; wherein steps 2,3 and 4 are performed without the use of a nucleic acid extractionsolution other than the solution of step 1 and wherein steps 2, 3 and 4are performed using a high-throughput nucleic acid processing andanalysis system. In some embodiments a biological sample is collectedfrom a subject who has, may have, or desires to be tested for a pathogen(such as SARS-COV2). In some embodiments of the methods, the biologicalsample is collected and is subsequently contacted with the solution;wherein detergents inactivate the infectious agent rendering it nolonger infectious, and where the detergents solubilize lipids andproteins to expose the nucleic acid; wherein nucleic acid is exposed toa cationic polymer promoting structured ordering of charged moieties onthe nucleic acid, encouraging nucleic acid condensation; wherein nucleicacid is exposed to a crowding agent and salt such as alcohol or PEG andsodium chloride which promotes immobilization of the nucleic acid on afunctionalized charged residue on the paramagnetic beads; wherein a tubeis received in a laboratory or processing site, is accessioned, andwhere a magnetic field is applied to the tube to immobilize the beads tothe inner side of the tube; wherein immobilized beads are washed with asolution containing an alcohol; wherein concentrated nucleic acid iseluted from the beads with water or nucleic acid buffer; wherein theeluted nucleic acid is analyzed using a test system. In some embodimentsof the methods, the biological sample is collected via nasopharyngealswab from a subject who has, may have, or desires to be tested for apathogen (such as SARS-COV2) and is subsequently contacted with thesolution; wherein detergents inactivate the infectious agent renderingit no longer infectious, and where the detergents solubilize lipids andproteins to expose the nucleic acid; wherein nucleic acid is exposed toa cationic polymer promoting structured ordering of charged moieties onthe nucleic acid, encouraging nucleic acid condensation; wherein nucleicacid is exposed to a crowding agent and salt such as alcohol or PEG andsodium chloride which promotes immobilization of the nucleic acid on afunctionalized charged residue on the paramagnetic beads; wherein a tubeis received in a laboratory or processing site, is accessioned, andwhere a magnetic field is applied to the tube to immobilize the beads tothe inner side of the tube; wherein immobilized beads are washed with asolution containing an alcohol; wherein concentrated nucleic acid iseluted from the beads with water or nucleic acid buffer; wherein theeluted nucleic acid is analyzed using a test system; and wherein a testresult is delivered back to a subject an appropriate treatment isapplied to the subject according to the test result.

A method, the method comprising providing a solution or kit of any oneof the preceding embodiments; wherein a biological sample is contactedwith the solution in a vessel or tube; and wherein the nucleic acid isstored, extracted, immobilized, purified and concentrated in said vesselor tube.

In certain embodiments of any of the solutions or methods providedherein, the solutions used do not include guanidine (such a guanidinesalt, for example, guanidine thiocyanate, guanidine isothiocyanate,guanidine HCl, thiocyanic acid with guanidine). In some embodiments, thesolutions do not include thiocyanate. In some embodiments of any of thesolutions or methods provided herein, the solutions used do not includesodium iodide. In some embodiments of any of the solutions or methodsprovided herein, the solutions used do not include urea. In someembodiments of any of the solutions or methods provided herein, thesolutions used do not include an alkaline solution. In some embodimentsof any of the solutions or methods provided herein, the solutions useddo not include an enzyme such as, for example, proteinase K, trypsin,dispase, collagenase, cellulase, chitinase, lysozyme, lipase, zymolase,or liticase. In some embodiments of any of the solutions or methodsprovided herein, the solutions used do not include any of the following:guanidine (such a guanidine salt, for example, guanidine thiocyanate,guanidine isothiocyanate, guanidine HCl, thiocyanic acid withguanidine), thiocyanate, sodium iodide, urea, an alkaline solution, oran enzyme such as, for example, proteinase K, trypsin, dispase,collagenase, cellulase, chitinase, lysozyme, lipase, zymolase, orliticase

BRIEF DESCRIPTION OF THE DRAWINGS

Some novel features various aspect and embodiments of this disclosureare set forth with particularity in the appended embodiments. A betterunderstanding of the features and advantages of the present aspect andembodiments can be obtained by reference to the following detaileddescription that sets forth illustrative embodiments, in which theprinciples of the invention are utilized, and the accompanying drawingsof which:

FIG. 1 illustrates an increase in repeatability and stability of thesample in the Enhanced Preservation Media as compared to Viral TransportMedia after immediate extraction following exposure to the sample.

FIG. 2 illustrates an increase in repeatability and stability of thesample in the Enhanced Preservation Media as compared to Viral TransportMedia after extraction 24 hours following exposure to the sample.

FIG. 3 illustrates sample stability within the Enhanced PreservationMedia after up to 1 week of initial collection.

FIG. 4 illustrates sample stability within the Enhanced PreservationMedia after exposure to standard shipping conditions.

FIG. 5 illustrates the efficacy for the integrated extraction aspect ofthe Enhanced Preservation Media for use in high-throughput screeningprotocols.

FIG. 6 illustrates the ability of the Enhanced Preservation Media toprotect the sample from degradation.

SPECIFIC EMBODIMENTS

In addition to aspects and embodiments contemplated elsewhere in thepresent disclosure, the following specific embodiments are expresslycontemplated:

-   1. A solution comprising a chelating agent, a detergent, a salt, a    cationic polymer and a pH buffering agent.-   2. A solution comprising a chelating agent, a detergent, a salt, and    a cationic polymer.-   3. A solution comprising a chelating agent, a first detergent, a    second detergent, a salt, a cationic polymer and a pH buffering    agent.-   4. A solution comprising a chelating agent, a first detergent, a    second detergent, a salt, and a cationic polymer.-   5. A solution comprising a first and second chelating agent, a first    and second detergent, a salt, a cationic polymer and a pH buffering    agent.-   6. A solution comprising a chelating agent, a detergent, a salt, a    pH buffering agent, a crowding agent and paramagnetic beads.-   7. A solution comprising a chelating agent, a detergent, a salt, a    crowding agent and paramagnetic beads-   8. A solution comprising a chelating agent, a first detergent, a    second detergent, a salt, a pH buffering agent, a crowding agent and    paramagnetic beads.-   9. A solution comprising a chelating agent, a first detergent, a    second detergent, a salt, a crowding agent and paramagnetic beads.-   10. A solution comprising a chelating agent, a detergent, a salt, a    cationic polymer, a pH buffering agent and an antimicrobial.-   11. A solution comprising a chelating agent, a first detergent, a    second detergent, a salt, a cationic polymer, a pH buffering agent    and an antimicrobial.-   12. A solution comprising a chelating agent, a detergent, a salt, a    cationic polymer, a pH buffering agent, a crowding agent,    paramagnetic beads and an antimicrobial.-   13. A solution comprising a chelating agent, a detergent, a salt, a    cationic polymer, a crowding agent, paramagnetic beads and an    antimicrobial.-   14. A solution comprising a chelating agent, a first detergent, a    second detergent, a salt, a cationic polymer, a pH buffering agent,    a crowding agent, paramagnetic beads and an antimicrobial.-   15. solution comprising a chelating agent, a first detergent, a    second detergent, a salt, a cationic polymer, a crowding agent,    paramagnetic beads and an antimicrobial.-   16. A solution comprising a chelating agent, an ionic detergent, a    non-ionic detergent, a salt, a cationic polymer, a pH buffering    agent, and a crowding agent.-   17. A solution comprising a chelating agent, an ionic detergent, a    non-ionic detergent, a salt, a cationic polymer, and a crowding    agent.-   18. A solution comprising a chelating agent, an ionic detergent, a    non-ionic detergent, a salt, and a crowding agent and paramagnetic    beads.-   19. A solution comprising a chelating agent, an ionic detergent that    is between 0.1-1.0%, a non-ionic detergent that is between 0.1-1.0%,    a salt, a cationic polymer, a pH buffering agent, and a crowding    agent.-   20. A solution comprising a chelating agent, an ionic detergent that    is between 0.1-1.0%, a non-ionic detergent that is between 0.1-1.0%,    a salt, a cationic polymer, a pH buffering agent, a crowding agent    and paramagnetic beads.-   21. A solution comprising a chelating agent, an ionic detergent, a    non-ionic detergent, a salt, a cationic polymer, a pH buffering    agent, and a crowding agent; wherein the crowding agent is one or    more selected from the group consisting of ethanol, isopropanol and    PEG.-   22. A solution comprising a chelating agent, an ionic detergent, a    non-ionic detergent, a salt, a cationic polymer, a pH buffering    agent, a crowding agent and paramagnetic beads; wherein the crowding    agent is one or more selected from the group consisting of ethanol,    isopropanol and PEG.-   23. A solution comprising a chelating agent, an ionic detergent that    is between 0.1-1.0%, a non-ionic detergent that is between 0.1-1.0%,    a salt, a cationic polymer, a pH buffering agent, and a crowding    agent; wherein the crowding agent is one or more selected from the    group consisting of ethanol, isopropanol and PEG.-   24. A solution comprising a chelating agent, an ionic detergent that    is between 0.1-1.0%, a non-ionic detergent that is between 0.1-1.0%,    a salt, a cationic polymer, a pH buffering agent, a crowding agent;    and an antimicrobial.-   25. A solution comprising a chelating agent, an ionic detergent that    is between 0.1-1.0%, a non-ionic detergent that is between 0.1-1.0%,    a salt, a cationic polymer, a pH buffering agent, a crowding agent;    and an antimicrobial; wherein the crowding agent is one or more    selected from the group consisting of ethanol, isopropanol and PEG.-   26. A solution comprising a chelating agent, an ionic detergent, a    non-ionic detergent, a salt, a cationic polymer, a pH buffering    agent, a crowding agent, paramagnetic beads and an antimicrobial    agent.-   27. A solution comprising a chelating agent, an ionic detergent that    is between 0.1-1.0%, a non-ionic detergent that is between 0.1-1.0%,    a salt, a cationic polymer, a pH buffering agent, a crowding agent;    and an antimicrobial agent.-   28. A solution comprising a chelating agent, an ionic detergent that    is between 0.1-1.0%, a non-ionic detergent that is between 0.1-1.0%,    a salt, a cationic polymer, a pH buffering agent, a crowding agent,    paramagnetic beads and an antimicrobial; wherein the crowding agent    is one or more selected from the group consisting of ethanol,    isopropanol and PEG.-   29. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent selected from the group    consisting of enterobactin, Deferasirox (DFS), Deferiprone (DFP),    Deferoxamine Mesylate (DFM), EDTA, and EGTA.-   30. The solution of any one of the preceding embodiments wherein the    solution includes a first chelating agent and a second chelating    agent.-   31. The solution of any one of the preceding embodiments wherein the    solution includes a first detergent and a second detergent.-   32. The solution of any one of the preceding embodiments, wherein    the solution includes an ionic detergent and a non-ionic detergent.-   33. The solution of any one of the preceding embodiments wherein the    chelating agent is enterobactin.-   34. The solution of any one of the preceding embodiments wherein the    chelating agent is deferasirox.-   35. The solution of any one of the preceding embodiments wherein the    chelating agent is deferiprone.-   36. The solution of any one of the preceding embodiments wherein the    chelating agent is deferoxamine mesylate.-   37. The solution of any one of the preceding embodiments wherein the    chelating agent is EDTA.-   38. The solution of any one of the preceding embodiments wherein the    chelating agent is EGTA.-   39. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is between 25-750 μM in    the solution.-   40. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is between 100-200 μM in    the solution.-   41. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is between 100-150 μM in    the solution.-   42. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 100 μM in the    solution.-   43. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 110 μM in the    solution.-   44. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 120 μM in the    solution.-   45. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 125 μM in the    solution.-   46. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 130 μM in the    solution-   47. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 140 μM in the    solution.-   48. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is between 10-100 mM in    the solution.-   49. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is between 50-100 mM in    the solution.-   50. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is between 50-75 mM in the    solution.-   51. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 50 mM in the    solution.-   52. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 52.5 mM in the    solution.-   53. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 55 mM in the    solution.-   54. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 57.5 mM in the    solution.-   55. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 60 mM in the    solution.-   56. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 62.5 mM in the    solution.-   57. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 65 mM in the    solution.-   58. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 67.5 mM in the    solution.-   59. The solution of any one of the preceding embodiments wherein the    solution comprises a chelating agent that is about 70 mM in the    solution.-   60. The solution of any one of the preceding embodiments wherein the    solution comprises a first chelating agent that is between 50-100 mM    in the solution and a second chelating agent that is between 100-150    μM.-   61. The solution of any one of the preceding embodiments, wherein    the solution comprises a detergent selected from the group    consisting of Cholate, Deoxycholate, Sodium Dodecyl Sulfate,    Sarkosyl, DDM, Digitonin, NP-40, Triton X-100, Tween 20, and Tween    80.-   62. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent Triton X-100.-   63. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent Triton X-100 present in an    amount between 0.1-1.0% weight/volume of the solution.-   64. The solution of any one of the preceding embodiments, wherein    the solution comprises detergent cholate.-   65. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent cholate in an amount between    0.1-0.5% weight/volume of the solution.-   66. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent Deoxycholate.-   67. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent Deoxycholate in an amount    between 0.1-0.5% weight/volume of the solution.-   68. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent Sodium Dodecyl Sulfate.-   69. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent Sodium Dodecyl Sulfate in an    amount between 0.1-1.0% weight/volume of the solution.-   70. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent Sarkosyl.-   71. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent Sarkosyl in an amount between    0.5-0.5% weight/volume of the solution.-   72. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent DDM.-   73. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent DDM in an amount between    0.2-1.0% weight/volume of the solution.-   74. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent digitonin.-   75. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent digitonin in an amount between    0.2-2.0% weight/volume of the solution.-   76. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent NP-40.-   77. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent NP-40 in an amount between    0.05-1.0% weight/volume of the solution.-   78. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent Tween 20.-   79. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent Tween 20 in an amount between    0.05-0.5% weight/volume of the solution.-   80. The solution of any one of the preceding embodiments, wherein    the solution comprises the detergent Tween 80.-   81. The solution of any one of the preceding embodiments, wherein    the solution comprises detergent Tween 80 in an amount between    0.05-0.5% weight/volume of the solution.-   82. The solution of any one of the preceding embodiments, wherein    the solution comprises a buffering agent selected from the group    consisting of Citrate, HEPES, Phosphate, and Tris.-   83. The solution of any one of the preceding embodiments, wherein    the buffering agent is Citrate.-   84. The solution of any one of the preceding embodiments, wherein    the buffering agent is Citrate, and the buffering agent is present    in an amount between 50-250 mM.-   85. The solution of any one of the preceding embodiments, wherein    the buffering agent is HEPES.-   86. The solution of any one of the preceding embodiments, wherein    the buffering agent is HEPES, and the buffering agent is present in    an amount between 25-150 mM.-   87. The solution of any one of the preceding embodiments, wherein    the buffering agent is Phosphate.-   88. The solution of any one of the preceding embodiments, wherein    the buffering agent is Phosphate, and the buffering agent is present    in an amount between 50-200 mM.-   89. The solution of any one of the preceding embodiments, wherein    the buffering agent is Tris.-   90. The solution of any one of the preceding embodiments, wherein    the buffering agent is Tris, and the buffering agent is present in    an amount between 25-250 mM.-   91. The solution of any one of the preceding embodiments, wherein    the solution comprises a crowding agent selected from the group    consisting of Ethanol, Isopropanol, PEG 4000, PEG6000, and PEG8000.-   92. The solution of any one of the preceding embodiments, wherein    the solution comprises a binding agent selected from the group    consisting of Ethanol, Isopropanol, PEG 4000, PEG6000, and PEG8000    and is present in an amount between 10-20% weight/volume of the    solution.-   93. The solution of any one of the preceding embodiments, wherein    the solution comprises binding agent PEG8000 and is present in an    amount between 12-18% weight/volume of the solution.-   94. The solution of any one of the preceding embodiments, wherein    the solution comprises sodium chloride, and is present in an amount    between 1-2M in the solution.-   95. The solution of any one of the preceding embodiments, wherein    the solution comprises a cationic polymer selected from the group    consisting of Poly-L-Arginine, Poly-D-Lysine, and Poly-L-Lysine.-   96. The solution of any one of the preceding embodiments, wherein    the solution comprises a cationic polymer selected from the group    consisting of Poly-L-Arginine, Poly-D-Lysine, and Poly-L-Lysine and    is present in the solution in an amount between 10-100 mg/L.-   97. The solution of any one of the preceding embodiments, wherein    the solution comprises an antimicrobial selected from a group    consisting of penicillin, streptomycin, Amphotericin B, and a urine    Stabilur tablet.-   98. The solution of any one of the preceding embodiments, wherein    the solution comprises paramagnetic beads.-   99. The solution of any one of the preceding embodiments, wherein    the solution comprises paramagnetic beads that are 100 nm-10 μm; or    500 nm-5 μm; or 500 nm-2 μm; or 500 nm-1.5 μm; or 750 nm-1.25 μm; or    about 500 nm; or about 600 nm; or about 700 nm; or about 750 nm; or    about 800 nm; or about 900 nm; or about 1 μm; or about 1.1p m; or    about 1.2 μm; or about 1.25 μm; or about 1.3 μm; or about 1.4 μm; or    about 1.5 μm. In some embodiments, the paramagnetic beads are 1-100    nm; or 10-50 nm; or 10-20 nm; or 20-30 nm; or 30-40 nm; or 40-50 nm;    or 5-25 nm; or 15-35 nm; or 20-40 nm in diameter.-   100. The solution of any one of the preceding embodiments, wherein    the solution comprises paramagnetic beads that include 30-70%    magnetite; or 40-60% magnetite; or 30-50% magnetite; or 35-45%    magnetite; or 40-50% magnetite; or 50-70% magnetite; or 55-65%    magnetite; or about 30% magnetite; or about 35% magnetite; or about    40% magnetite; or about 45% magnetite; or about 50% magnetite; or    about 55% magnetite; or about 60% magnetite; or about 65% magnetite;    or about 70% magnetite.-   101. The solution of any one of the preceding embodiments, wherein    the solution comprises paramagnetic beads present in the solution in    an amount that is 1 mg/L-10 g/L; or 5 mg/L-5 g/L; or 25 mg/L-2.5    g/L; or 50 mg/L-Ig/L; or 50 mg/L-500 mg/L; or 50 mg/L-200 mg/L; or    50 mg/L-150 mg/L; or 75 mg/L-125 mg/L; or about 1 mg/L; or about 10    mg/L; or about 50 mg/L; or about 60 mg/L; or about 70 mg/L; or about    75 ml g/L; or about 80 mg/L; or about 90 mg/L; or about 100 ng/L; or    about 110 mg/L; or about 120 mg/L; or about 125 mg/L; or about 130    mg/L; or about 140 mg/L; or about 150 mg/L; or about 175 mg/L; or    about 200 mg/L; or about 250 mg/L; or about 500 mg/L; or about 750    mg/L; or about 1.0 g/L; or about 2.5 g/L; or about 5 g/L; or about    7.5 g/L; or about 10 g/L.-   102. The solution of any one of the preceding embodiments, wherein    the solution comprises paramagnetic beads; wherein the paramagnetic    beads comprise one or more selected from the group consisting of    carboxylate modified beads, amine-blocked beads, oligo(dT) beads,    streptavidin beads, silica based or coated beads.-   103. A solution of any one of the preceding embodiments wherein the    solution comprises about 62.5 mM EDTA, 125 μM DFM, 0.5% SDS, 0.5%    Triton X, 1.5M NaCl, 12.5 μM Poly-L-Lysine, 125 mM Tris pH8 and 15%    PEG8000.-   104. A solution of any one of the preceding embodiments wherein the    solution comprises about 62.5 mM EDTA, 125 μM DFM, 0.5% SDS, 0.5%    Triton X, 1.5M NaCl, 12.5 μM Poly-L-Lysine, 125 mM Tris pH8, 15%    PEG8000 and at least one microbial agent.-   105. A solution of any one of the preceding embodiments wherein the    solution comprises about 62.5 mM EDTA, 125 μM DFM, 0.5% SDS, 0.5%    Triton X, 1.5M NaCl, 12.5 μM Poly-L-Lysine, 125 mM Tris pH8, 15%    PEG8000, at least one microbial agent and paramagnetic beads.-   106. A solution of any one of the preceding embodiments wherein the    solution comprises about 62.5 mM EDTA, 125 μM DFM, 0.5% SDS, 0.5%    Triton X, 1.5M NaCl, 12.5 μM Poly-L-Lysine, 125 mM Tris pH8, 15%    PEG8000, 125 Units/ml penicillin, 125 mg/ml streptomycin, and 312    ng/ml Amphotericin B.-   107. A solution of any one of the preceding embodiments wherein the    solution comprises about 62.5 mM EDTA, 125 μM DFM, 0.5% SDS, 0.5%    Triton X, 1.5M NaCl, 12.5 μM Poly-L-Lysine, 125 mM Tris pH8, 15%    PEG8000, 125 Units/ml penicillin, 125 mg/ml streptomycin, 312 ng/ml    Amphotericin B and paramagnetic beads.-   108. A solution comprising a chelating agent, a detergent, a salt, a    cationic polymer, a pH buffering agent, a crowding agent,    paramagnetic beads and an antimicrobial, wherein the chelating agent    is present in an amount between either 25-750 μM or 10-100 mM in the    solution, and wherein the detergent is present in an amount between    0.1-1.0% weight/volume of the solution, and wherein the salt is    present in an amount between 1-2M in the solution, and wherein the    cationic polymer is present in an amount between 10-100 mg/L in the    solution, wherein the buffering agent is present in an amount    between 25-250 mM in the solution, and wherein the crowding agent is    present in an amount between 10-20% of the solution.-   109. A solution comprising a chelating agent, a detergent, a salt, a    cationic polymer, a pH buffering agent, a crowding agent,    paramagnetic beads and an antimicrobial, wherein the chelating agent    comprises one or more selected from the group consisting of    enterobactin, deferasirox (DFS), Deferiprone (DFP), Deferoxamine    Mesylate, EDTA, and EGTA. wherein the detergent comprises one or    more selected from the group consisting of Cholate, Deoxycholate,    Sodium Dodecyl Sulfate, sarkosyl, DDM, Digitonin, NP-40, Triton    X-100, Tween 20, and Tween 80, wherein the salt is sodium chloride,    wherein the cationic polymer comprises one or more selected from the    group consisting of Poly-L-Arginine, Poly-D-Lysine, and    Poly-L-Lysine, wherein the buffering agent comprises one or more    selected from the group consisting of Citrate, HEPES, Phosphate, and    Tris, wherein the crowding agent comprises on or more selected from    the group consisting of Ethanol, Isopropanol, PEG 4000, PEG6000, and    PEG8000, and wherein the antimicrobial is selected from a group    consisting of penicillin, streptomycin, Amphotericin B, and a urine    stabilur tablet.-   110. A solution comprising a chelating agent, a detergent, a salt, a    cationic polymer, a pH buffering agent, a crowding agent,    paramagnetic beads and an antimicrobial, wherein the chelating agent    comprises one or more selected from the group consisting of    enterobactin, Deferasirox (DFS), Deferiprone (DFP), Deferoxamine    Mesylate, EDTA, and EGTA, wherein the chelating agent is present in    an amount between either 25-750 μM or 10-100 mM in the solution; and    wherein the detergent comprises one or more selected from the group    consisting of Cholate, Deoxycholate, Sodium Dodecyl Sulfate,    Sarkosyl, DDM, Digitonin, NP-40, Triton X-100, Tween 20, and Tween    80, and wherein the detergent is present in an amount between    0.1-1.0% of the solution; and wherein the salt is sodium chloride,    and wherein the salt is present in an amount of 1.5M in solution;    and wherein the cationic polymer comprises one or more selected from    the group consisting of Poly-L-Arginine, Poly-D-Lysine, and    Poly-L-Lysine, and wherein the cationic polymer is present in an    amount between 10-100 mg/L in the solution; wherein the buffering    agent comprises one or more selected from the group consisting of    Citrate, HEPES, Phosphate, and Tris, and wherein the buffering agent    is present in an amount between 25-250 mM in the solution; wherein    the crowding agent comprises on or more selected from the group    consisting of Ethanol, Isopropanol, PEG 4000, PEG6000, and PEG8000,    and wherein the crowding agent is present in an amount between    10-20% of the solution; and wherein the antimicrobial is selected    from a group consisting of penicillin, streptomycin, Amphotericin B,    and urine Stabilur tablet.-   111. A solution comprising a chelating agent, a detergent, a salt, a    cationic polymer, a pH buffering agent, a crowding agent,    silica-coated beads and an antimicrobial, wherein the chelating    agent comprises EDTA, wherein the chelating agent is present in an    amount between 10-100 mM in the solution; and wherein the detergents    comprise Sodium Dodecyl Sulfate and Triton X-100, and wherein the    detergents are both present in an amount of 0.5% of the solution;    and wherein the salt is sodium chloride, and wherein the salt is    present in an amount of 1.5M in solution; and wherein the cationic    polymer comprises Poly-L-Lysine, and wherein the cationic polymer is    present in an amount between 10-100 mg/L in the solution; wherein    the buffering agent is TRIS, pH 8, and wherein the buffering agent    is present at 125 mM in the solution; wherein the crowding agent    comprises PEG8000, and wherein the crowding agent is present in an    amount between 15% of the solution; and wherein the antimicrobial is    selected from a group consisting of penicillin, streptomycin,    Amphotericin B, and urine Stabilur tablet.-   112. The solution of any of the preceding embodiments wherein the    solution is a collection/preservation, and extraction solution.-   113. The solution of any of the preceding embodiments wherein the    solution is a collection/preservation, and extraction solution for    samples from a biological sample containing nucleic acids.-   114. The solution of any of the preceding embodiments wherein the    solution is a collection/preservation, and extraction solution for    samples from a biological sample containing nucleic acids, wherein    the nucleic acids bind to paramagnetic beads within the solution.-   115. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least 6 hours, 12    hours, 18 hours, 24 hours, two days, three days, four days, five    days, six days, seven days, eight days, nine days, ten days, two    weeks, three weeks, one month, two months, three months, four    months, five months, six months, one year, or two years.-   116. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least 6 hours.-   117. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least 12 hours.-   118. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least 18 hours.-   119. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least 24 hours.-   120. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least two days.-   121. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least three days.-   122. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least four days.-   123. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least five days.-   124. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least six days.-   125. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least seven days.-   126. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least eight days.-   127. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least nine days.-   128. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least ten days.-   129. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least two weeks.-   130. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least three weeks.-   131. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least one month.-   132. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least two months.-   133. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least three months.-   134. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least four months.-   135. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least five months.-   136. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least six months.-   137. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least one year.-   138. The solution of any one of the preceding embodiments wherein    nucleic acid is stable in the solution for at least two years.-   139. A kit comprising a solution of any one of the preceding    embodiments.-   140. A kit comprising a solution of any one of the preceding    embodiments in a tube.-   141. A kit comprising a solution of any one of the preceding    embodiments; wherein the solution is in a tube configured to accept    a biological sample from a sampling swab into the solution.-   142. A kit comprising a solution of any one of the preceding    embodiments; wherein the solution is in a tube configured to accept    saliva into the solution.-   143. A kit comprising a solution of any one of the preceding    embodiments in a tube and a sample device suitable for collecting a    biological sample.-   144. A kit comprising a solution of any one of the preceding    embodiments in a tube configured to be suitable for high throughput    nucleic acid extraction and evaluation.-   145. A kit comprising a solution comprising a chelating agent, a    detergent, a salt, a cationic polymer and a pH buffering agent in a    tube configured to be suitable for high throughput nucleic acid    extraction and evaluation.-   146. A kit comprising a solution comprising a first and second    chelating agent, a first and second detergent, a salt, a cationic    polymer and a pH buffering agent in a tube configured to be suitable    for high throughput nucleic acid extraction and evaluation.-   147. A kit comprising a chelating agent, a detergent, a salt, a pH    buffering agent, a crowding agent and paramagnetic beads in a tube    configured to be suitable for high throughput nucleic acid    extraction and evaluation.-   148. A kit comprising a solution comprising a chelating agent, a    detergent, a salt, a cationic polymer, a pH buffering agent and an    antimicrobial in a tube configured to be suitable for high    throughput nucleic acid extraction and evaluation.-   149. A kit comprising a solution comprising a chelating agent, a    detergent, a salt, a cationic polymer, a pH buffering agent, a    crowding agent, paramagnetic beads and an antimicrobial in a tube    configured to be suitable for high throughput nucleic acid    extraction and evaluation.-   150. A kit comprising a solution comprising a chelating agent, a    detergent, a salt, a cationic polymer, a pH buffering agent, a    crowding agent, paramagnetic beads and an antimicrobial, wherein the    chelating agent is present in an amount between either 25-750 μM or    10-100 mM in the solution, and wherein the detergent is present in    an amount between 0.1-1.0% weight/volume of the solution, and    wherein the salt is present in an amount between 1-2M in the    solution, and wherein the cationic polymer is present in an amount    between 10-100 mg/L in the solution, and wherein the pH buffering    agent is present in an amount between 25-250 mM and wherein the    crowding agent is present in an amount between 10-20% of the    solution; wherein the solution is in a tube configured to be    suitable for high throughput nucleic acid extraction and evaluation.-   151. A kit comprising a solution comprising a chelating agent, a    detergent, a salt, a cationic polymer, a pH buffering agent, a    crowding agent, paramagnetic beads and an antimicrobial, wherein the    chelating agent comprises one or more selected from the group    consisting of enterobactin, Deferasirox (DFS), Deferiprone (DFP),    Deferoxamine Mesylate, EDTA, and EGTA. wherein the detergent    comprises one or more selected from the group consisting of Cholate,    Deoxycholate, Sodium Dodecyl Sulfate, Sarkosyl, DDM, Digitonin,    NP-40, Triton X-100, Tween 20, and Tween 80, wherein the salt is    sodium chloride, wherein the cationic polymer comprises one or more    selected from the group consisting of Poly-L-Arginine,    Poly-D-Lysine, and Poly-L-Lysine, wherein the buffering agent    comprises one or more selected from the group consisting of Citrate,    HEPES, Phosphate, and Tris, wherein the crowding agent comprises on    or more selected from the group consisting of Ethanol, Isopropanol,    PEG 4000, PEG6000, and PEG8000, and wherein the antimicrobial is    selected from a group consisting of penicillin, streptomycin,    Amphotericin B, and urine Stabilur tablet; wherein the solution is    in a tube configured to be suitable for high throughput nucleic acid    extraction and evaluation.-   152. A kit comprising a solution comprising a chelating agent, a    detergent, a salt, a cationic polymer, a pH buffering agent, a    crowding agent, paramagnetic beads and an antimicrobial, wherein the    chelating agent comprises one or more selected from the group    consisting of enterobactin, Deferasirox (DFS), Deferiprone (DFP),    Deferoxamine Mesylate, EDTA, and EGTA, wherein the chelating agent    is present in an amount between either 25-750 μM or 10-100 mM in the    solution; and wherein the detergent comprises one or more selected    from the group consisting of Cholate, Deoxycholate, Sodium Dodecyl    Sulfate, Sarkosyl, DDM, Digitonin, NP-40, Triton X-100, Tween 20,    and Tween 80, and wherein the detergent is present in an amount    between 0.1-1.0% of the solution; and wherein the salt is sodium    chloride, and wherein the salt is present in the amount of 1.5M in    solution; and wherein the cationic polymer comprises one or more    selected from the group consisting of Poly-L-Arginine,    Poly-D-Lysine, and Poly-L-Lysine, and wherein the cationic polymer    is present in an amount between 10-100 mg/L in the solution; wherein    the buffering agent comprises one or more selected from the group    consisting of Citrate, HEPES, Phosphate, and Tris, and wherein the    buffering agent is present in an amount between 25-250 mM in the    solution; wherein the crowding agent comprises on or more selected    from the group consisting of Ethanol, Isopropanol, PEG 4000,    PEG6000, and PEG8000, and wherein the crowding agent is present in    an amount between 10-20% of the solution; and wherein the    antimicrobial are selected from a group consisting of penicillin,    streptomycin, Amphotericin B, and urine Stabilur tablet; wherein the    solution is in a tube configured to be suitable for high throughput    nucleic acid extraction and evaluation.-   153. A kit, the kit comprising a solution of any one of the    preceding embodiments; wherein the solution is in a tube configured    to accept a biological sample from a sampling swab into the    solution, wherein the swab is contacted with a subject suspected of    being infected with a pathogen.-   154. A kit, the kit comprising a solution of any one of the    preceding embodiments; wherein the solution is in a tube configured    to accept a biological sample from a sampling swab into the    solution, wherein the swab is contacted with a subject suspected of    being infected with a pathogen, wherein the pathogen is SARS-CoV2.-   155. A method, the method comprising providing a solution or kit of    any one of the preceding embodiments; wherein a biological sample is    contacted with the solution.-   156. A method, the method comprising providing a solution or kit of    any one of the preceding embodiments; wherein a biological sample is    contacted with the solution in a vessel or tube; and wherein the    nucleic acid is stored, extracted, immobilized, purified and    concentrated in said vessel or tube.-   157. A method comprising providing a solution or kit of any one of    the preceding embodiments;    -   wherein a sample comprising nucleic acid is contacted with the        solution; and wherein the nucleic acid from the sample is tested        for the presence or absence of a genetic marker or nucleic acid        markers of a pathogen.-   158. A method comprising providing a solution of any one of the    preceding embodiments; wherein a sample comprising nucleic acid is    contacted with the solution; and wherein the nucleic acid from the    sample is evaluated for the presence or absence of a genetic marker    or a pathogen without use of an independent nucleic acid extraction    system.-   159. A method comprising providing a solution of any one of the    preceding embodiments; wherein a sample comprising nucleic acid is    contacted with the solution; and wherein the nucleic acid from the    sample is evaluated for the presence or absence of a genetic marker    or a pathogen without use of a independent nucleic acid extraction    system, the pathogen is one or more selected from the group    consisting of (1) viruses of families including, but not limited to,    Adenoviridae, Herpesviridae, Papillomaviridae, Polyomarviridae,    Poxviridae, Parvoviridae, Reoviridae, Astroviridae, Caliciviridae,    Coronaviridae, Flaviviridae, Hepeviridae, Matonaviridae,    Picornaviridae, Arenaviridae, Bunyarviridae, Filoviridae,    Orthomyxoviridae, Paramyxoviridae, Pneumoviridae, Rhabdoviridae,    Retroviridae, and Hepadnaviridae, (2) bacteria of genera including,    but not limited to, Bacillus, Bartonella, Bordetella, Borrelia,    Brucella, Campylobacter, Chlamydia, Chlamydophila, Clostridium,    Corynebacterium, Enterococcus, Escherichia, Francisella,    Haemophilus, Helicobacter, Legionella, Leptospira, Listeria,    Mycobacterium, Mycoplasma, Neisseria, Pseudomonas, Rickettsia,    Salmonella, Shigella, Staphylococcus, Streptococcus, Treponema,    Ureaplasma, Vibrio, and Yersinia, (3) fungi of genera including, but    not limited to, Aspergillus, Candida, Cryptococcus, Histoplasma,    Pneumocystis, and Stachybotrys, and (4) protozoa and algae    including, but not limited to, Prototheca wickerhami, Plasmodium,    Entamoeba, Giardia, Trypanosoma brucei, Toxoplasma gondii,    Acanthamoeba, Leishmania, Babesia, Balamuthia mandrillaris,    Cryptosporidium, Cyclospora, and Naegleria fowler.-   160. A method comprising providing a solution or kit of any one of    the preceding embodiments; wherein a sample comprising nucleic acid    is contacted with the solution; wherein the sample is collected from    a subject suspected of being infected with SARS-CoV2.-   161. A method comprising providing a solution or kit of any one of    the preceding embodiments; wherein a sample comprising nucleic acid    is contacted with the solution; wherein the sample is collected via    nasopharyngeal swab.-   162. A method comprising providing a solution or kit of any one of    the preceding embodiments; wherein a sample comprising nucleic acid    is contacted with the solution; wherein the sample is collected via    nasopharyngeal swab and the sample is collected from a subject    suspected of being infected with SARS-CoV2 or a subject desiring to    be tested for a SARS-CoV2 infection.-   163. A method comprising providing a solution of any one of the    preceding embodiments having paramagnetic beads, wherein (1) a    biological sample that has, or may have, nucleic acid from a    pathogen is contacted with the solution such that the nucleic acid    from the biological sample can bind to the paramagnetic beads, (2)    the tube is exposed to a magnetic field to isolate the beads from    the solution, (3) the beads are washed and nucleic acid is    subsequently eluted, and (4) the nucleic acid that was bound to the    beads is analyzed for the presence or absence of pathogenic nucleic    acid.-   164. A method, said method comprising providing a solution of any    one of the preceding embodiments having paramagnetic beads,    wherein (1) a biological sample that has, or may have, nucleic acid    from a pathogen is contacted with the solution such that the nucleic    acid from the biological sample can bind to the paramagnetic    beads, (2) the beads are isolated from the solution by one or more    of exposure to a magnetic field, centrifugation or filtration, (3)    the beads are washed and nucleic acid is subsequently eluted,    and (4) the nucleic acid that was bound to the beads is analyzed for    the presence or absence of pathogenic nucleic acid.-   165. A method comprising providing a solution of any one of the    preceding embodiments having paramagnetic beads, wherein (1) a    biological sample that has, or may have, nucleic acid from a    pathogen is contacted with the solution such that the nucleic acid    from the biological sample can bind to the paramagnetic beads, (2)    the beads are isolated from the solution by one or more of exposure    to a magnetic field, centrifugation or filtration, (3) the beads are    washed and nucleic acid is subsequently eluted, and (4) the nucleic    acid that was bound to the beads is analyzed for the presence or    absence of pathogenic nucleic acid; wherein at least 30%; or at    least 40%; or at least 50%; or at least 60%; or at least 70%; or at    least 75%; or at least 80%; or at least 85%; or at least 90%; or at    least 95% of the solution of step (1) that was contacted with the    biological sample is used in step (2).-   166. A method comprising providing a solution of any one of the    preceding embodiments having paramagnetic beads, wherein (1) a    biological sample that has, or may have, nucleic acid from a    pathogen is contacted with the solution such that the nucleic acid    from the biological sample can bind to the paramagnetic beads, (2)    the beads are isolated from the solution by one or more of exposure    to a magnetic field, centrifugation or filtration, (3) the beads are    washed and nucleic acid is subsequently eluted, and (4) the nucleic    acid that was bound to the beads is analyzed for the presence or    absence of pathogenic nucleic acid; wherein at least 30%; or at    least 40%; or at least 50%; or at least 60%; or at least 70%; or at    least 75%; or at least 80%; or at least 85%; or at least 90%; or at    least 95% of the total nucleic of the original biological sample is    still present after step (2).-   167. A method comprising providing a solution of any one of the    preceding embodiments; wherein the solution is contacted with a    biological sample and wherein at least 30%; or at least 40%; or at    least 50%; or at least 60%; or at least 70%; or at least 75%; or at    least 80%; or at least 85%; or at least 90%; or at least 95% of the    nucleic acid present in the biological sample is subjected to    nucleic acid analysis.-   168. A method comprising providing a solution of any one of the    preceding embodiments having paramagnetic beads, wherein (1) a    biological sample that has, or may have, nucleic acid from a    pathogen is contacted with the solution such that the nucleic acid    from the biological sample can bind to the paramagnetic beads, (2)    the tube is exposed to a magnetic field to isolate the beads from    the solution, (3) the beads are washed and nucleic acid is    subsequently eluted, and (4) the nucleic acid that was bound to the    beads is analyzed for the presence or absence of pathogenic nucleic    acid; wherein steps (1) and (2) are performed without the use of a    nucleic acid extraction solution other than the solution of step 1.-   169. A method comprising providing a solution of any one of the    preceding embodiments having paramagnetic beads, wherein (1) a    biological sample that has, or may have, nucleic acid from a    pathogen is contacted with the solution such that the nucleic acid    from the biological sample can bind to the paramagnetic beads, (2)    the tube is exposed to a magnetic field to isolate the beads from    the solution, (3) the beads are washed and nucleic acid is    subsequently eluted, and (4) the nucleic acid that was bound to the    beads is analyzed for the presence or absence of pathogenic nucleic    acid; wherein steps (1) and (2) are performed without the use of a    nucleic acid extraction solution other than the solution of step 1.-   170. A method comprising providing a solution of any one of the    preceding embodiments having paramagnetic beads, wherein (1) a    biological sample that has, or may have, nucleic acid from a    pathogen is contacted with the solution such that the nucleic acid    from the biological sample can bind to the paramagnetic beads, (2)    the tube is exposed to a magnetic field to isolate the beads from    the solution, (3) the beads are washed and nucleic acid is    subsequently eluted, and (4) the nucleic acid that was bound to the    beads is analyzed for the presence or absence of pathogenic nucleic    acid; wherein steps 2, 3 and 4 are performed without the use of a    nucleic acid extraction solution other than the solution of step 1    and wherein steps (1) and (2) are performed using a high-throughput    nucleic acid processing and analysis system.-   171. The composition or method of any one of the preceding    embodiments wherein said sample or biological sample is from an    animal.-   172. The composition or method of any one of the preceding    embodiments wherein said sample or biological sample is from a human    subject.-   173. The composition or method of any one of the preceding    embodiments wherein said sample or biological sample is from a human    subject, wherein said human subject is suspected of SARS-CoV2 virus    or desires to be tested for the SARS-CoV2 virus.-   174. The composition or method of any one of the preceding    embodiments wherein said sample or biological sample is from a food    product.-   175. The composition or method of any one of the preceding    embodiments wherein said sample or biological sample is an    environmental sample.-   176. The composition or method of any one of the preceding    embodiments wherein solutions used do not include any guanidine salt    (e.g., guanidine thiocyanate, guanidine isothiocyanate, guanidine    HCl, or thiocyanic acid with guanidine).-   177. The composition or method of any one of the preceding    embodiments wherein solutions used do not include sodium iodide.-   178. The composition or method of any one of the preceding    embodiments wherein the solutions used do not include urea.-   179. The composition or method of any one of the preceding    embodiments with the proviso that the solutions do not include an    alkaline solution.-   180. The composition or method of any one of the preceding    embodiments wherein solutions used do not include any enzyme    selected from the group consisting of proteinase K, trypsin,    dispase, collagenase, cellulase, chitinase, lysozyme, lipase,    zymolase, and liticase.    -   The below Table A provides non-limiting examples of possible        formulations of the disclosure; in addition to the specified        components, each of the following solutions includes one or more        antimicrobial agents as provided herein and paramagnetic beads        as provided herein.

TABLE A 1st Chelating 2nd Chelating Cationic pH Buffering Crowding AgentAgent 1st Detergent 2nd Detergent Salt Polymer Agent Agent Sv100 EDTA,DFS, 100 μM Cholate, 0.1% DDM, 0.5% NaCl, Poly-L-Lysine, PhosphatePEG6000, 125 mM 1.5M <5 kDa, 50 μM pH7, 15% 100 mM Sv101 EDTA, DFP, 250μM Cholate, 0.2% NP-40, 0.5% NaCl, Poly-L- Tris pH8, PEG6000, 62.5 mM1.5M Arginine, 250 mM 18% <0 kDa, 25 μM Sv102 EGTA, DFM, 250 μM Cholate,0.3% Triton X-100, NaCl, Poly-L-Lysine, Tris pH8, PEG8000, 125 mM 0.2%1.5M <150 kDa, 125 mM 13% 12.5 μM Sv103 EGTA, DFS, 200 μM Cholate, 0.4%Triton X-100, NaCl, Poly-L-Lysine, HEPES PEG8000, 62.5 mM 1.0% 1.5M <300kDa, pH7.5, 15% 12.5 μM 100 mM Sv104 EDTA, DFS, 100 μM Cholate, 0.5%Tween-20, NaCl, Poly-D- HEPES PEG8000, 50 mM 0.1% 1.5M Lysine, pH7.5,18% <300 kDa, 200 mM 12.5 μM Sv105 EDTA, DFP, 250 μM Deoxycholate, DDM,0.5% NaCl, Poly-L- Phosphate PEG6000, 62.5 mM 0.1% 1.5M Arginine, pH7,15% <15 kDa, 100 mM 150 μM Sv106 EDTA, DFM, 250 μM Deoxycholate, NP-40,0.5% NaCl, Poly-L-Lysine, Tris pH8, PEG6000, 125 mM 0.2% 1.5M <70 kDa,125 mM 18% 12.5 μM Sv107 EGTA, DFS, 200 μM Deoxycholate, Triton C-100,NaCl, Poly-L-Lysine, HEPES PEG8000, 62.5 mM 0.3% 0.2% 1.5M <150 kDa,pH7.5, 15% 25 μM 100 mM Sv108 EGTA, DFM, 250 μM Deoxycholate, Tween-20,NaCl, Poly-L-Lysine, HEPES PEG8000, 125 mM 0.4% 0.1% 1.5M <300 kDa,pH7.5, 18% 12.5 μM 200 mM Sv109 EDTA, DFM, 125 μM SDS, .5% Triton X, .5%NaCl, Poly-L-Lysine, Tris pH8, PEG8000, 62.5 mM 1.5M 12.5 μM 125 mM 15%Sv110 EDTA, DFM, 125 μM SDS, 0.5% Triton X, .5% NaCl, Poly-L-Lysine,Tris pH8, PEG8000, 62.5 mM 1.5M <5 kDa, 125 mM 15% 12.5 μM Sv111 EDTA,DFS, 100 μM SDS, 0.1% DDM, 0.5% NaCl, Poly-L- Phosphate PEG6000, 125 mM1.5M Arginine, pH7, 15% <15 kDa, 50 μM 100 mM Sv112 EGTA, DFP, 250 μMSDS, 0.2% NP-40, 0.5% NaCl, Poly-L-Lysine, Tris pH8, PEG6000, 62.5 mM1.5M <70 kDa, 25 μM 250 mM 18% Sv113 EGTA, DFM, 250 μM SDS, 0.3% TritonX-100, NaCl, Poly-L-Lysine, HEPES PEG8000, 125 mM 0.2% 1.5M <150 kDa,pH7.5, 13% 12.5 μM 100 mM Sv114 EGTA, DFS, 200 μM SDS, 0.7% TritonX-100, NaCl, Poly-L-Lysine, HEPES PEG8000, 62.5 mM 1.0% 1.5M <300 kDa,pH7.5, 15% 125 μM 200 mM Sv115 EDTA, DFS, 100 μM SDS, 1.0% Tween-20,NaCl, Poly-D- Phosphate PEG8000, 50 mM 0.1% 1.5M Lysine, pH7, 18% <300kDa, 100 mM 150 μM Sv116 EDTA, DFP, 250 μM Sarkosyl, 0.5% DDM, 0.5%NaCl, Poly-L-Lysine, Tris pH8, PEG6000, 62.5 mM 1.5M <5 kDa, 25 μM 125mM 15% Sv117 EGTA, DFM, 250 μM Sarkosyl, 1.0% NP-40, 0.5% NaCl, Poly-L-Tris pH8, PEG6000, 125 mM 1.5M Arginine, 250 mM 18% <70 kDa, 12.5 μMPhosphate PEG8000, Sv118 EGTA, DFS, 200 μM Sarkosyl, 2.0% Triton X-100,NaCl, Poly-L-Lysine, pH7, 13% 50 mM 0.2% 1.5M <150 kDa, 100 mM 50 μMSv119 EGTA, DFM, 125 μM Sarkosyl, 3.0% Triton X-100, NaCl,Poly-L-Lysine, HEPES PEG8000, 125 mM 1.0% 1.5M <300 kDa, pH7.5, 15% 25μM 100 mM Sv120 EDTA, DFS, 100 μM Sarkosyl, 5.0% Tween-20, NaCl, Poly-D-HEPES PEG8000, 62.5 mM 0.1% 1.5M Lysine, pH7.5, 18% <300 kDa, 200 mM 10μM Sv121 EDTA, DFP, 250 μM Deoxycholate, Tween-20, NaCl, Poly-L-Lysine,Tris pH8, PEG8000, 100 mM 0.5% 0.1% 1.5M <70 kDa, 250 mM 16% 150 μMSv122 EDTA, DFP, 250 μM Deoxycholate, DDM, 0.5% LiCl, Poly-L-Lysine,HEPES PEG6000, 62.5 mM 0.3% 1.5M <70 kDa, pH7.5, 15% 150 μM 100 mM Sv123EGTA, DFM, 250 μM SDS, 0.3% DDM, 0.5% LiCl, Poly-L-Lysine, HEPESPEG6000, 125 mM 1.5M <70 kDa, pH7.5, 15% 12.5 μM 100 mM Sv124 EGTA, DFS,100 μM Cholate, 0.4% DDM, 0.5% LiCl, Poly-L- HEPES PEG6000, 62.5 mM 1.5MArginine, pH7.5, 15% <15 kDa, 50 μM 100 mM Sv125 EDTA, DFM, 250 μMCholate, 0.5% NP-40, 0.5% LiCl, Poly-L- HEPES PEG6000, 50 mM 1.5MArginine, pH7.5, 18% <70 kDa, 200 mM 12.5 μM Sv126 EDTA, DFS, 100 μMDeoxycholate, NP-40, 0.5% LiCl, Poly-D- HEPES PEG6000, 62.5 mM 0.4% 1.5MLysine, pH7.5, 18% <300 kDa, 200 mM 12.5 μM Sv127 EGTA, DFS, 100 μM SDS,0.7% NP-40, 0.5% LiCl, Poly-D- HEPES PEG6000, 125 mM 1.5M Lysine, pH7.5,18% <300 kDa, 200 mM 150 μM Sv128 EGTA, DFP, 250 μM Sarkosyl, 3.0%NP-40, 0.5% LiCl, Poly-L- HEPES PEG6000, 62.5 mM 1.5M Arginine, pH7.5,18% <70 kDa, 25 μM 100 mM Sv129 EGTA, DFP, 250 μM Sarkosyl, 5.0% TritonX-100, LiCl, Poly-L- HEPES PEG8000, 125 mM 0.2% 1.5M Arginine, pH7.5,13% <15 kDa, 200 mM 150 μM Sv130 EGTA, DFP, 250 μM Deoxycholate, TritonX-100, LiCl, Poly-L-Lysine, Phosphate PEG8000, 100 mM 0.1% 0.2% 1.5M <5kDa, 25 μM pH7, 15% 100 mM Sv131 EDTA, DFS, 100 μM SDS, 0.1% TritonX-100, LiCl, Poly-D- Phosphate 62.5 mM 0.2% 1.5M Lysine, pH7, PEG8000,<300 kDa, 100 mM 13% 10 μM Sv132 EDTA, DFM, 250 μM Sarkosyl, 2.0% TritonX-100, LiCl, Poly-L-Lysine, Phosphate PEG8000, 125 mM 0.2% 1.5M <150kDa, pH7, 13% 12.5 μM 100 mM Sv133 EGTA, DFM, 250 μM SDS, 0.1% Tween-20,LiCl, Poly-L-Lysine, Phosphate PEG8000, 50 mM 0.1% 1.5M <300 kDa, pH7,18% 100 mM 12.5 μM Tris pH8, PEG8000, Sv134 EGTA, DFM, 250 μM Sarkosyl,0.5% Tween-20, LiCl, Poly-L-Lysine, 125 mM 18% 125 mM 0.1% 1.5M <150kDa, 12.5 μM Sv135 EDTA, DFM, 125 μM Deoxycholate, Tween-20, LiCl,Poly-L-Lysine, Tris pH8, PEG8000, 62.5 mM 0.2% 0.1% 1.5M <300 kDa, 125mM 15% 25 μM Sv136 EDTA, DFS, 200 μM Cholate, 0.3% Tween-20, LiCl,Poly-L-Lysine, Tris pH8, PEG8000, 125 mM 0.1% 1.5M <150 kDa, 125 mM 18%50 μM Sv137 EGTA, DFS, 200 μM Cholate, 0.2% Tween-20, LiCl,Poly-L-Lysine, Tris pH8, PEG8000, 62.5 mM 0.1% 1.5M <300 kDa, 250 mM 18%12.5 μM Sv138 EGTA, DFS, 200 μM Sarkosyl, 1.0% Triton X-100, LiCl,Poly-L-Lysine, Tris pH8, PEG8000, 125 mM 1.0% 1.5M <150 kDa, 250 mM 15%25 μM Sv139 EGTA, DFP, 250 μM SDS, 0.2% Triton X-100, LiCl,Poly-L-Lysine, Tris pH8, PEG8000, 62.5 mM 1.0% 1.5M <70 kDa, 25 μM 250mM 15% Sv140 EDTA, DFS, 200 μM Deoxycholate, Triton X-100, LiCl,Poly-L-Lysine, Tris pH8, PEG8000, 50 mM 0.5% 1.0% 1.5M <300 kDa, 250 mM15% 125 μM Sv141 EDTA, DFM, 125 μM SDS, 0.5% Triton X, .5% LiCl, 1.5MPoly-L-Lysine, Tris pH8, PEG8000, 62.5 mM <5 kDa, 125 mM 15% 12.5 μMSv142 EDTA, DFP, 250 μM Deoxycholate, Triton X-100, MgCl2, Poly-L- TrispH8, PEG8000, 62.5 mM 0.5% 0.2% 1.5M Arginine, 250 mM 15% <70 kDa, 25 μMSv143 EDTA, DFM, 250 μM Deoxycholate, Triton X-100, MgCl2,Poly-L-Lysine, Tris pH8, PEG8000, 62.5 mM 0.2% 0.2% 1.5M <150 kDa, 125mM 13% 12.5 μM Sv144 EDTA, DFS, 200 μM SDS, 0.1% Triton X-100, MgCl2,Poly-L-Lysine, Phosphate PEG8000, 125 mM 1.0% 1.5M <300 kDa, pH7, 15%12.5 μM 100 mM Sv145 EDTA, DFS, 100 μM Sarkosyl, 1.0% Tween-20, MgCl2,Poly-D-Lysine, Tris pH8, PEG8000, 62.5 mM 0.1% 1.5M <300 kDa, 250 mM 18%12.5 μM Sv146 EDTA, DFP, 250 μM Cholate, 0.5% Tween-20, MgCl2, Poly-L-HEPES PEG8000, 125 mM 0.1% 1.5M Arginine, pH7.5, 18% <15 kDa, 200 mM 150μM Sv147 EDTA, DFM, 250 μM SDS, 0.1% Triton X-100, MgCl2, Poly-L-Lysine,Phosphate PEG8000, 125 mM 1.0% 1.5M <70 kDa, pH7, 15% 12.5 μM 100 mMSv148 EGTA, DFS, 200 μM Cholate, 0.2% Triton X-100, MgCl2,Poly-L-Lysine, Tris pH8, PEG8000, 62.5 mM 1.0% 1.5M <150 kDa, 250 mM 15%25 μM Sv149 EGTA, DFM, 250 μM Deoxycholate, Tween-20, MgCl2,Poly-L-Lysine, Phosphate PEG8000, 125 mM 0.1% 0.1% 1.5M <300 kDa, pH7,18% 12.5 μM 100 mM Sv150 EGTA, DFP, 250 μM Sarkosyl, 0.5% DDM, 0.5%MgCl2, Poly-L-Lysine, Tris pH8, PEG8000, 62.5 mM 1.5M <70 kDa, 125 mM15% 150 μM Sv151 EGTA, DFP, 250 μM Sarkosyl, 5.0% DDM, 0.5% MgCl2,Poly-L-Lysine, HEPES PEG6000, 50 mM 1.5M <5 kDa, 251AM pH7.5, 15% 200 mMSv152 EGTA, DFM, 250 μM Cholate, 0.3% Triton X-100, MgCl2, Poly-L- TrispH8, PEG8000, 125 mM 0.2% 1.5M Arginine, 125 mM 13% <70 kDa, 12.5 μMSv153 EGTA, DFS, 200 μM Deoxycholate, Tween-20, MgCl2, Poly-L-Lysine,HEPES PEG8000, 50 mM 0.4% 0.1% 1.5M <150 kDa, pH7.5, 18% 50 μM 200 mMSv154 EGTA, DFM, 125 μM SDS, 0.3% DDM, 0.5% MgCl2, Poly-L-Lysine, HEPESPEG6000, 125 mM 1.5M <300 kDa, pH7.5, 15% 25 μM 100 mM Sv155 EGTA, DFS,100 μM Sarkosyl, 3.0% NP-40, 0.5% MgCl2, Poly-D- HEPES PEG6000, 100 mM1.5M Lysine, pH7.5, 18% <300 kDa, 100 mM 10 μM Sv156 EDTA, DFS, 100 μMSarkosyl, 2.0% Triton X-100, MgCl2, Poly-L- Phosphate PEG8000, 62.5 mM0.2% 1.5M Arginine, pH7, 13% <15 kDa, 50 μM 100 mM Sv157 EGTA, DFP, 250μM Cholate, 0.4% NP-40, 0.5% MgCl2, Poly-L-Lysine, HEPES PEG6000, 50 mM1.5M <70 kDa, 25 μM pH7.5, 18% 100 mM Sv158 EGTA, DFM, 250 μMDeoxycholate, NP-40, 0.5% MgCl2, Poly-L-Lysine, HEPES PEG6000, 62.5 mM0.3% 1.5M <150 kDa, pH7.5, 18% 12.5 μM 100 mM Sv159 EGTA, DFS, 200 μMSDS, 0.2% NP-40, 0.5% MgCl2, Poly-L-Lysine, Tris pH8, PEG6000, 125 mM1.5M <300 kDa, 250 mM 18% 125 μM Sv160 EGTA, DFS, 1001AM SDS, 0.7%Tween-20, MgCl2, Poly-D- HEPES PEG8000, 62.5 mM 0.1% 1.5M Lysine, pH7.5,15% <300 kDa, 200 mM 150 μM Sv161 EDTA, DFM, 125 μM SDS, 0.5% Triton X,.5% MgCl2, Poly-L-Lysine, Tris pH8, PEG8000, 62.5 mM 1.5M <5 kDa, 125 mM15% 12.5 μM Sv162 EGTA, DFP, 250 μM Cholate, 0.2% Tween-20, Na2SO4,Poly-L- Tris pH8, PEG8000, 62.5 mM 0.1% 1.5M Arginine, 250 mM 15% <15kDa, 150 μM Sv163 EGTA, DFP, 250 μM Cholate, 0.3% NP-40, 0.5% Na2SO4,Poly-L-Lysine, Tris pH8, PEG6000, 125 mM 1.5M <5 kDa, 25 μM 125 mM 18%Sv164 EGTA, DFS, 100 μM Cholate, 0.4% DDM, 0.5% Na2SO4, Poly-L- HEPESPEG6000, 62.5 mM 1.5M Arginine, pH7.5, 15% <15 kDa, 50 μM 100 mM Sv165EGTA, DFP, 250 μM Cholate, 0.5% NP-40, 0.5% Na2SO4, Poly-L- HEPESPEG6000, 50 mM 1.5M Arginine, pH7.5, 18% <70 kDa, 25 μM 200 mM Sv166EGTA, DFM, 250 μM Deoxycholate, Tween-20, Na2SO4, Poly-L-Lysine,Phosphate PEG8000, 125 mM 0.1% 0.1% 1.5M <70 kDa, pH7, 18% 12.5 μM 100mM Sv167 EGTA, DFM, 250 μM Deoxycholate, Tween-20, Na2SO4, Poly-L- TrispH8, PEG8000, 62.5 mM 0.2% 0.1% 1.5M Arginine, 125 mM 18% <70 kDa, 12.5μM Sv168 EGTA, DFP, 250 μM Deoxycholate, NP-40, 0.5% Na2SO4,Poly-L-Lysine, HEPES PEG6000, 125 mM 0.3% 1.5M <70 kDa, 25 μM pH7.5, 18%Sv169 EDTA, DFM, 250 μM Deoxycholate, DDM, 0.5% Na2SO4, Poly-L-Lysine,100 mM 62.5 mM 0.4% 1.5M <150 kDa, HEPES PEG6000, 12.5 μM pH7.5, 15%Sv170 EDTA, DFS, 200 μM Deoxycholate, DDM, 0.5% Na2SO4, Poly-L-Lysine,200 mM 62.5 mM 0.5% 1.5M <150 kDa, Tris pH8, PEG6000, 25 μM 250 mM 15%Sv171 EDTA, DFS, 200 μM Sarkosyl, 0.5% Tween-20, Na2SO4, Poly-L-Lysine,Tris pH8, PEG8000, 125 mM 0.1% 1.5M <150 kDa, 125 mM 18% 50 μM Sv172EGTA, DFM, 250 μM Sarkosyl, 1.0% Triton X-100, Na2SO4, Poly-L-Lysine,Tris pH8, PEG8000, 50 mM 0.2% 1.5M <150 kDa, 250 mM 13% 12.5 μM Sv173EGTA, DFS, 100 μM Sarkosyl, 2.0% Tween-20, Na2SO4, Poly-D-Lysine,Phosphate PEG8000, 50 mM 0.1% 1.5M <300 kDa, pH7, 18% 12.5 μM 100 mMSv174 EDTA, DFM, 250 μM Sarkosyl, 3.0% Triton X-100, Na2SO4,Poly-L-Lysine, HEPES PEG8000, 62.5 mM 0.2% 1.5M <300 kDa, pH7.5, 13%12.5 μM 100 mM Sv175 EDTA, DFP, 250 μM Sarkosyl, 5.0% Triton X-100,Na2SO4, Poly-L-Lysine, HEPES PEG8000, 125 mM 1.0% 1.5M <70 kDa, pH7.5,15% 150 μM 200 mM Sv176 EGTA, DFS, 100 μM SDS, 0.1% Triton X-100,Na2SO4, Poly-D- Phosphate PEG8000, 125 mM 0.2% 1.5M Lysine, pH7, 13%<300 kDa, 100 mM 10 μM Sv177 EDTA, DFS, 100 μM SDS, 0.2% Triton X-100,Na2SO4, Poly-D- Tris pH8, PEG8000, 62.5 mM 1.0% 1.5M Lysine, 250 mM 15%<300 kDa, 150 μM Sv178 EDTA, DFS, 200 μM SDS, 0.3% Triton X-100, Na2SO4,Poly-L-Lysine, HEPES PEG8000, 125 mM 0.2% 1.5M <300 kDa, pH7.5, 15% 12.5μM 100 mM Sv179 EGTA, DFM, 125 μM SDS, 0.7% NP-40, 0.5% Na2SO4,Poly-L-Lysine, HEPES PEG6000, 62.5 mM 1.5M <300 kDa, pH7.5, 18% 25 μM200 mM Sv180 EGTA, DFS, 200 μM SDS, 1.0% Triton X-100, Na2SO4,Poly-L-Lysine, Phosphate PEG8000, 100 mM 1.0% 1.5M <300 kDa, pH7, 15%125 μM 100 mM Sv181 EDTA, DFM, 125 μM SDS, 0.5% Triton X, .5% Na2SO4,Poly-L-Lysine, Tris pH8, PEG8000, 62.5 mM 1.5M <5 kDa, 125 mM 15% 12.5μM Sv182 EDTA, DFS, 200 μM Deoxycholate, NP-40, 0.5% KCl, 1.5MPoly-L-Lysine, Phosphate PEG6000, 100 mM 0.1% <150 kDa, pH7, 18% 25 μM100 mM Sv183 EDTA, DFM, 250 μM Sarkosyl, 0.5% Triton X-100, KCl, 1.5MPoly-L-Lysine, Tris pH8, PEG8000, 125 mM 0.2% <150 kDa, 125 mM 13% 12.5μM Sv184 EDTA, DFS, 200 μM SDS, 0.1% Triton X-100, KCl, 1.5MPoly-L-Lysine, Phosphate PEG8000, 125 mM 1.0% <300 kDa, pH7, 15% 12.5 μM100 mM Sv185 EDTA, DFS, 100 μM Cholate, 0.2% Tween-20, KCl, 1.5MPoly-D-Lysine, Tris pH8, PEG8000, 125 mM 0.1% <300 kDa, 250 mM 18% 12.5μM Sv186 EDTA, DFM, 250 μM Deoxycholate, DDM, 0.5% KCl, 1.5MPoly-L-Lysine, Tris pH8, PEG6000, 50 mM 0.2% <300 kDa, 125 mM 15% 12.5μM Sv187 EDTA, DFS, 200 μM Sarkosyl, 1.0% NP-40, 0.5% KCl, 1.5MPoly-L-Lysine, Tris pH8, PEG6000, 40 mM <300 kDa, 250 mM 18% 125 μMSv188 EDTA, DFM, 125 μM SDS, 0.2% Triton X-100, KCl, 1.5M Poly-L-Lysine,Tris pH8, PEG8000, 62.5 mM 0.2% <300 kDa, 250 mM 15% 25 μM Sv189 EDTA,DFS, 100 μM Cholate, 0.3% Tween-20, KCl, 1.5M Poly-D- Tris pH8, PEG8000,62.5 mM 0.1% Lysine, 125 mM 18% <300 kDa, 10 μM Sv190 EDTA, DFP, 250 μMDeoxycholate, Tween-20, KCl, 1.5M Poly-L- HEPES PEG8000, 62.5 mM 0.3%0.1% Arginine, pH7.5, 15% <15 kDa, 100 mM 150 μM Sv191 EDTA, DFS, 100 μMSarkosyl, 2.0% DDM, 0.5% KCl, 1.5M Poly-L- Phosphate PEG6000, 62.5 mMArginine, pH7, 15% <15 kDa, 50 μM 100 mM Sv192 EGTA, DFS, 200 μM SDS,0.3% NP-40, 0.5% KCl, 1.5M Poly-L-Lysine, HEPES PEG6000, 125 mM <150kDa, pH7.5, 18% 50 μM 100 mM Sv193 EGTA, DFS, 100 μM Cholate, 0.5%Triton X-100, KCl, 1.5M Poly-D- HEPES PEG8000, 125 mM 0.2% Lysine,pH7.5, 13% <300 kDa, 200 mM 150 μM Sv194 EGTA, DFP, 250 μM Deoxycholate,Triton X-100, KCl, 1.5M Poly-L-Lysine, HEPES PEG8000, 125 mM 0.4% 1.0%<5 kDa, 25 μM pH7.5, 15% Sv195 EGTA, DFM, 250 μM Deoxycholate, Tween-20,KCl, 1.5M Poly-L-Lysine, 200 mM 125 mM 0.5% 0.1% <70 kDa, Tris pH8,PEG8000, 12.5 μM 250 mM 18% Sv196 EDTA, DFM, 250 μM Sarkosyl, 5.0% DDM,0.5% KCl, 1.5M Poly-L-Lysine, HEPES PEG6000, 50 mM <150 kDa, pH7.5, 15%12.5 μM 200 mM Sv197 EGTA, DFP, 250 μM SDS, 1.0% NP-40, 0.5% KCl, 1.5MPoly-L- Phosphate PEG6000, 62.5 mM Arginine, pH7, 18% <70 kDa, 25 μM 100mM Sv198 EGTA, DFM, 250 μM Cholate, 0.4% Triton X-100, KCl, 1.5M Poly-L-HEPES PEG8000, 62.5 mM 0.2% Arginine, pH7.5, 13% <70 kDa, 100 mM 12.5 μMSv199 EGTA, DFP, 250 μM Sarkosyl, 3.0% Triton X-100, KCl, 1.5MPoly-L-Lysine, HEPES PEG8000, 62.5 mM 1.0% <70 kDa, 25 μM pH7.5, 15% 100mM Sv200 EGTA, DFP, 250 μM SDS, 0.7% Tween-20, KCl, 1.5M Poly-L-Lysine,HEPES PEG8000, 62.5 mM 0.1% <70 kDa, pH7.5, 18% 150 μM 200 mM Sv201EDTA, DFM, 125 μM SDS, 0.5% Triton X, .5% KCl, 1.5M Poly-L-Lysine, TrispH8, PEG8000, 62.5 mM <5 kDa, 125 mM 15% 12.5 μM

The inventions illustratively described herein may be practiced in theabsence of any element or elements, limitation or limitations which isnot specifically disclosed herein. The terms and expressions which havebeen employed are used as terms of description and not of limitation,and there is no intention that in the use of such terms and expressionsof excluding any equivalents of the features shown and described orportions thereof, but it is recognized that various modifications arepossible within the scope of the invention claimed. Thus, it should beunderstood that although the present inventions have been specificallydisclosed by preferred embodiments and optional features, modificationand variation of the concepts herein disclosed may be resorted to bythose skilled in the art, and that such modifications and variations areconsidered to be within the scope of the inventions as defined by theappended embodiments and elsewhere in the disclosure.

The contents of the articles, patents, and patent applications, and allother documents and electronically available information mentioned orcited herein, are hereby incorporated by reference in their entirety tothe same extent as if each individual publication was specifically andindividually indicated to be incorporated by reference. Applicantsreserve the right to physically incorporate into this application anyand all materials and information from any such articles, patents,patent applications, or other documents.

The term “about” as used herein means in quantitative terms plus orminus 10%. For example, “About 3%” would encompass 2.7-3.3% and “About10%” would encompass 9-11%”. Moreover, where “about” is used herein inconjunction with a quantitative term it is understood that in additionto the value plus or minus 10%, the exact value of the quantitative termis also contemplated and described—for example, the term “about 3%”expressly contemplates, describes and includes exactly 3%.

The inventions illustratively described herein may suitably be practicedin the absence of any element or elements, limitation or limitations,not specifically disclosed herein. Thus, for example, the terms“comprising”, “including,” containing”, etc. shall be read expansivelyand without limitation. Additionally, the terms and expressions employedherein have been used as terms of description and not of limitation, andthere is no intention in the use of such terms and expressions ofexcluding any equivalents of the features shown and described orportions thereof, but it is recognized that various modifications arepossible within the scope of the invention claimed. Thus, it should beunderstood that although the present invention has been specificallydisclosed by preferred embodiments and optional features, modificationand variation of the inventions embodied therein herein disclosed may beresorted to by those skilled in the art, and that such modifications andvariations are considered to be within the scope of various aspects andembodiments of inventions contemplated herein.

Certain aspects and embodiments of inventions have been describedbroadly and generically herein. Each of the narrower species andsubgeneric groupings falling within the generic disclosure also formpart of some aspects and embodiments of inventions contemplated herein.This includes the generic description of inventions with a proviso ornegative limitation removing any subject matter from the genus,regardless of whether or not the excised material is specificallyrecited herein.

In addition, where features or aspects of the invention are described interms of Markush groups, those skilled in the art will recognize thatsome aspects and embodiments of inventions contemplated herein are alsothereby described in terms of any individual member or subgroup ofmembers of the Markush group.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following embodiments define the scope of the invention and thatmethods and structures within the scope of these embodiments and theirequivalents be covered thereby.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the invention, it will be understood thatmodifications and variations are encompassed within the spirit and scopeof the instant disclosure. The preferred methods and materials are nowdescribed.

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.In the case of conflict, the specification, including definitions, willcontrol.

Examples Example 1: Preparation of an EPM-IX Solution

An EPM-IX solution is made by making a solution having the componentsand amounts of a solution listed on Table A. The EPM-IX solution furtherhas paramagnetic beads in a concentration of 100 mg/L; wherein the beadsare “Speedbeads” with a 60% magnate content and having an averagediameter of 1 μm.

Example 2: Comparison of EPM-IX to Viral Transport Media (VTM) withImmediate Extraction

SARS-CoV2 positive-control (ZeptoMetrix) was diluted directly into 1 mlof EMP-IX or VTM, mixed by vortexing for 10 sec, and incubated for 20minutes at room temperature. VTM samples were extracted using the QIAampViral RNA Mini Kit (Qiagen) according to CDC protocol (CDC-006-00019)recommendation of 100 ul for extraction and 100 ul for elution. ViralRNA yields were assessed using the CDC 2019-Novel Coronavirus(2019-nCoV) Real-Time RT-PCR Diagnostic Panel and are show in FIG. 1 andTable 1. Ct values are for both probes N1 and N2. Note that Ctdifferentials exist on a log₂-scale, so that a Ct difference of 1 equalsa yield difference of 2-fold and a Ct difference of 2 equals a yielddifference of 4-fold.

TABLE 1a Convergent Enhanced Preservation Media (EPM-IX); N1 probeSARS-CoV2 Rep 1 Rep 2 Rep 3 Rep 4 Average SD (ul) (Ct) (Ct) (Ct) (Ct)(Ct) (Ct) 15 25.0 26.8 25.6 26.7 26.0 0.9  3 29.1 27.5 29.9 28.6 28.81.0

TABLE 1b CDC Viral Transport Media (VTM); N1 probe SARS-CoV2 Rep 1 Rep 2Rep 3 Rep 4 Average SD (ul) (Ct) (Ct) (Ct) (Ct) (Ct) (Ct) 15 32.0 29.430.5 30.0 30.5 1.1  3 35.1 35.0 31.3 34.3 33.9 1.8

TABLE 1c Convergent Enhanced Preservation Media (EPM-IX); N2 probeSARS-CoV2 Rep 1 Rep 2 Rep 3 Rep 4 Average SD (ul) (Ct) (Ct) (Ct) (Ct)(Ct) (Ct) 15 25.9 26.8 25.5 26.6 26.2 0.6  3 29.0 26.1 29.3 28.5 28.21.4

TABLE 1d CDC Viral Transport Media (VTM); N2 probe SARS-CoV2 Rep 1 Rep 2Rep 3 Rep 4 Average SD (ul) (Ct) (Ct) (Ct) (Ct) (Ct) (Ct) 15 32.1 29.730.6 30.1 30.6 1.1  3 35.1 35.6 31.7 34.7 34.3 1.7

TABLE 1e ΔCt (Ct^(VTM)-Ct^(EPM)); [Fold improvement] SARS-CoV2 (ul) N1N2 15 4.5 [23x] 4.4 [21x] 3 5.1 [34x] 6.1 [69x]

Example 3: Comparison of EPM-IX to Viral Transport Media (VTM) Following24 hr Incubation

SARS-CoV2 positive-control (ZeptoMetrix) was diluted directly into 1 mlof EMP-IX or VTM, mixed by vortexing for 10 sec, and incubated for 24hrs at room temperature. VTM samples were extracted using the QIAampViral RNA Mini Kit (Qiagen) according to CDC protocol (CDC-006-00019)recommendation of 100 ul for extraction and 100 ul for elution. ViralRNA yields were assessed using the CDC 2019-Novel Coronavirus(2019-nCoV) Real-Time RT-PCR Diagnostic Panel and are shown graphicallyin FIG. 2. Ct values for probes N1 and N2. Note that Ct differentialsexist on a log₂-scale, so that a Ct difference of 1 equals a yielddifference of 2-fold and a Ct difference of 2 equals a yield differenceof 4-fold.

TABLE 2a Convergent Enhanced Preservation Media (EPM-IX); N1 probeSARS-CoV2 Rep 1 Rep 2 Rep 3 Rep 4 Average SD (ul) (Ct) (Ct) (Ct) (Ct)(Ct) (Ct) 15 27.3 26.2 27.1 27.0 26.9 0.5  3 28.6 29.5 30.3 29.4 29.50.7

TABLE 2b CDC Viral Transport Media (VTM); N1 probe SARS-CoV2 Rep 1 Rep 2Rep 3 Rep 4 Average SD (ul) (Ct) (Ct) (Ct) (Ct) (Ct) (Ct) 15 30.4 29.929.9 30.0 30.1 0.3  3 33.6 33.5 34.0 33.6 33.7 0.3

TABLE 2c Convergent Enhanced Preservation Media (EPM-IX); N2 probeSARS-CoV2 Rep 1 Rep 2 Rep 3 Rep 4 Average SD (ul) (Ct) (Ct) (Ct) (Ct)(Ct) (Ct) 15 27.1 27.6 27.0 27.1 27.2 0.3  3 28.1 29.8 30.8 29.3 29.51.1

TABLE 2d CDC Viral Transport Media (VTM); N2 probe SARS-CoV2 Rep 1 Rep 2Rep 3 Rep 4 Average SD (ul) (Ct) (Ct) (Ct) (Ct) (Ct) (Ct) 15 30.4 30.130.3 30.6 30.4 0.2  3 34.7 33.9 35.5 34.2 34.6 0.7

TABLE 2e ΔCt (Ct^(VTM)-Ct^(EPM)); [Fold improvement] SARS-CoV2 (ul) N1N2 15 3.2 [9x]  3.2 [9x]  3 4.2 [18x] 5.1 [34x]

Example 4: EPM-IX Performance Time-Course at Room Temperature

SARS-CoV2 positive-control (ZeptoMetrix) was diluted directly into 1 mlof EPM-IX, mixed by vortexing for 10 see, and incubated at roomtemperature for a time-course up to 1 week. 3 ul of ZeptoMetrix controlwas added to each tube, and incubations, extractions, and PCR wereperformed in triplicate. Viral RNA yields were assessed using the CDC2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel andare represented graphically in FIG. 3. Ct values for probes N1 and N2are reported.

TABLE 3a Immediate SARS-CoV2 Rep 1 Rep 2 Rep 3 Average SD Probe (Ct)(Ct) (Ct) (Ct) (Ct) N1 31.1 29.3 30.0 30.1 0.9 N2 31.9 30.2 30.5 30.81.0

TABLE 3b 24 hours SARS-CoV2 Rep 1 Rep 2 Rep 3 Average SD Probe (Ct) (Ct)(Ct) (Ct) (Ct) N1 29.0 30.1 29.7 29.6 0.5 N2 27.9 30.6 30.2 29.6 1.4

TABLE 3c 48 hours SARS-CoV2 Rep 1 Rep 2 Rep 3 Average SD Probe (Ct) (Ct)(Ct) (Ct) (Ct) N1 28.6 30.1 28.1 28.9 1.1 N2 29.2 30.7 29.0 29.6 0.9

TABLE 3d 1 week SARS-CoV2 Rep 1 Rep 2 Rep 3 Average SD Probe (Ct) (Ct)(Ct) (Ct) (Ct) N1 29.3 28.0 29.3 28.9 0.8 N2 30.1 28.6 28.2 29.0 1.0

Example 5: EPM-IX Performance Under Extreme Summer Shipping Conditions

A mid-turbinate swab was collected into 1 ml of EPM-IX and mixed byvortexing. Then 10 ul of SARS-CoV2 positive-control (ZeptoMetrix) wasadded to the EMP-IX mix and vortexed for 10 sec. The 1 ml sample wasthen split into 100 ul aliquots; 3 aliquots were immediately extracted,3 aliquots were incubated at RT for the full 56 hr time-course, and 3were added to a PCR block and subjected to the Summer Shippingtime-course outlined in Table 4a. Average Ct results are shown in FIG.4.

TABLE 4a Temperature Cycle Period Cycle Period Hours Total Time Hours40° C. 1 8 8 22° C. 2 4 12 40° C. 3 2 14 30° C. 4 36 50 40° C. 5 6 56

Viral and control RNA yields were assessed using the CDC 2019-NovelCoronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. Ct values forprobes N1, N2, and RP are reported in Table 4b-d.

TABLE 4b Immediate extraction SARS- CoV2 Rep 1 Rep 2 Rep 3 Average SD(ul) (Ct) (Ct) (Ct) (Ct) (Ct) N1 31.6 31.5 31.0 31.4 0.3 N2 32.1 32.132.3 32.1 0.1 RP 26.2 26.3 26.3 26.3 0.1

TABLE 4c 56 hr RT Incubation SARS- CoV2 Rep 1 Rep 2 Rep 3 Average SD(ul) (Ct) (Ct) (Ct) (Ct) (Ct) N1 30.8 30.3 31.3 30.8 0.5 N2 31.7 31.332.0 31.7 0.4 RP 26.4 25.8 26.5 26.2 0.4

TABLE 4d Summer Shipping Incubation SARS- CoV2 Rep 1 Rep 2 Rep 3 AverageSD (ul) (Ct) (Ct) (Ct) (Ct) (Ct) N1 31.3 32.7 32.7 32.2 0.8 N2 32.0 32.733.3 32.7 0.7 RP 27.8 27.0 27.6 27.5 0.4

Example 6: Testing EPM-IX Sample Washing Conditions

Volunteers performed mid-turbinate swabbing into EPM-IX test collectiontubes. Samples were split into two equal fractions and each extractedwith the same protocol except for EtOH wash condition. After beadclarification/magnetic binding from EPM-IX and complete removal ofsupernatant, the following washes were performed:

Double Wash: 800 ul of 80% EtOH is added, removed from magnet, mixed bypipet, and returned to the magnet for clarification. The first wash isremoved in its entirety and a second EtOH wash is performed with thetubes remaining on the magnet. Following the second wash, samples aredried for 5 minutes and resuspended in H2O.

Single Wash: Following magnetic binding and removal of EPM supernatant,800 ul of 80% EtOH is added to the tube and then removed after 30seconds, aspirating all EtOH wash. Tubes are never removed from themagnet. Sample are dried for 5 minutes and resuspended in H2O.

RNA yields were assessed using the CDC 2019-Novel Coronavirus(2019-nCoV) Real-Time RT-PCR Diagnostic Panel and are represented inFIG. 5. Ct values for probe RP are reported.

TABLE 5 SARS-CoV-2 Double Single on Probe Wash Bead Wash Sample 1 26.429.7 Sample 2 26.9 26.0 Sample 3 32.4 30.2 Sample 4 30.1 28 Sample 530.4 28.5 Sample 6 26.4 26.9 Sample 7 28.2 26.7 Sample 8 25.7 25.4Sample 9 27.9 27.3 Average 28.3 27.6

Example 7: EPM Protects Nucleic Acids by Physically Restricting Accessto the Molecule

Purified RNA was diluted in increasing concentrations of EPM that didnot contain the integrated extraction components of EPM-IX (i.e.detergents, crowding agent, and magnetic beads) and measured using theQubit HS RNA kit (Blue bars). RNA in EPM was then subjected to AMPurebead purification, eluted in H2O, and measured again by Qubit (Yellowline). Both assays were performed in triplicate and are presented inFIG. 6.

Example 8: Sample Processing Procedure Following Specimen Collection

I. Procedure

-   -   A. Sample Preparation        -   1. Obtain samples stored at RT.    -   B. If samples are refrigerated, allow samples to sit at RT for        30 minutes until samples have warmed to RT. Reagent Preparation        -   1. Prepare 80% Ethanol            -   1. Combine eight parts of molecular grade ethanol with                two parts of molecular grade water. 40 mL molecular                grade ethanol with 10 mL molecular grade water combined                in a 50 mL tube.    -   C. Purification        -   1. Mix sample collection tubes by pulse vortexing for 3-5            seconds.        -   2. For viruses, proceed to step 4. For pathogens with a cell            wall, cap tubes and place in an incubator at 95° C. for 15            minutes.            -   a. Allow tubes to return to RT.            -   b. Pulse vortex tubes 5 seconds.            -   c. Spin briefly in a minicentrifuge to bring down sample                contents from the lid or side of the tube.            -   d. Proceed to step 4.        -   3. Place the tubes on the DynaMag magnetic stand and            incubate at RT for 10 minutes to allow the beads to separate            from the solution.        -   4. Withdraw supernatant with P1000 pipette. Observe caution            to avoid disturbing the beads.        -   5. With tubes still on the magnet, pipette 900 μL of 80%            EtOH to each tube and let sit for 30 seconds.        -   6. Repeats steps 4 and 5 for a second wash.        -   7. Spin each tube briefly in a mini centrifuge to bring down            the contents of any sample in the lid or side of the tube.        -   8. Withdraw and discard the supernatant with a P1000 without            disturbing the beads.        -   9. Using P20 pipette, carefully remove all remnant EtOH at            the bottom of the tube.        -   10. Air-dry the beads at RT for 1-3 minutes with the caps            open while the tubes are still on the magnetic stand. Do not            over dry.        -   11. Remove tubes from magnet and pipette 30 μL of DNA            Suspension Buffer to each sample tube.        -   12. Pulse vortex each tube to resuspend the beads into the            solution and spin the tubes down. Use P200 pipette to            resuspend beads stuck to the side of the tube.        -   13. Incubate at RT for 2-5 minutes.        -   14. Return the tubes to the DynaMag 2 magnetic stand and            incubate at RT until clarified (˜3 minutes).        -   15. Aspirate the 25 μL eluents and transfer to a new 0.2 mL            12-Strip PCR Tube with the sample number for each sample.            Discard the 1.5 mL microcentrifuge tubes.    -   D. Sample Storage        -   1. Samples can be stored at −20° C.±5° C. if downstream            application are to be performed at a later date, or at            +2° C. to +8° C. if downstream application are to be            performed within 24 hours.

From the foregoing, it will be appreciated that, although specificembodiments of the invention have been described herein for purposes ofillustration, various modifications may be made without deviating fromthe spirit and scope of the invention. Accordingly, the invention is notlimited except as by the appended claims.

What is claimed is:
 1. A solution comprising a chelating agent, an ionicdetergent, a non-ionic detergent, a salt, a cationic polymer, a pHbuffering agent, a crowding agent, and paramagnetic beads.
 2. Thesolution of claim 1, wherein the solution comprises an ionic detergentthat is between 0.1-1.0% of the solution and a non-ionic detergent thatis between 0.1-1.0% of the solution.
 3. The solution of claim 1, whereinthe crowding agent is one or more selected from the group consisting ofethanol, isopropanol and PEG.
 4. The solution of claim 3, wherein thecrowding agent is PEG, and the PEG is one or more selected from thegroup consisting of PEG 4000, PEG6000, and PEG8000.
 5. The solution ofclaim 4, wherein the chelating agent is selected from the groupconsisting of enterobactin, Deferasirox (DFS), Deferiprone (DFP),Deferoxamine Mesylate, EDTA, EGTA and a combination thereof.
 6. Thesolution of claim 5, wherein the solution comprises a first chelatingagent and a second chelating agent.
 7. The solution of claim 6, whereinthe solution comprises EDTA and DFM.
 8. The solution of claim 7, whereinthe solution comprises an antimicrobial agent.
 9. The solution of claim8, wherein the solution comprises penicillin, streptomycin, AmphotericinB.
 10. The solution of claim 9, wherein the solution comprises about62.5 mM EDTA, 125 μM DFM, 0.5% SDS, 0.5% Triton X, 1.5M NaCl, 12.5 μMPoly-L-Lysine, 125 mM Tris pH8, 15% PEG8000, 125 Units/ml penicillin,125 mg/ml streptomycin, 312 ng/ml Amphotericin B and paramagnetic beads.11. The solution of claim 10, wherein the paramagnetic beads are presentin the solution in a concentration of 100 mg/L, have a 60% magnatecontent and an average diameter of 1 μm.
 12. A method comprisingproviding a solution comprising a chelating agent, an ionic detergent, anon-ionic detergent, a salt, a cationic polymer, a pH buffering agent, acrowding agent and paramagnetic beads and contacting the solution with abiological sample.
 13. The method of claim 12, wherein the solutioncomprises about 62.5 mM EDTA, 125 μM DFM, 0.5% SDS, 0.5% Triton X, 1.5MNaCl, 12.5 μM Poly-L-Lysine, 125 mM Tris pH8, 15% PEG8000, 125 Units/mlpenicillin, 125 mg/ml streptomycin, 312 ng/ml Amphotericin B andparamagnetic beads.
 14. The method of claim 13, wherein the biologicalsample is a sample from a human subject, a sample from a food source, orfrom an environmental source.
 15. The method of claim 14, wherein thebiological sample has, or is suspected of possibly having nucleic acidfrom a pathogen.
 16. The method of claim 15, wherein the pathogen is thepathogen is one or more selected from the group consisting of (1)viruses of families including, but not limited to, Adenoviridae,Herpesviridae, Papillomaviridae, Polyomarviridae, Poxviridae,Parvoviridae, Reoviridae, Astroviridae, Caliciviridae, Coronaviridae,Flaviviridae, Hepeviridae, Matonaviridae, Picornaviridae, Arenaviridae,Bunyarviridae, Filoviridae, Orthomyxoviridae, Paramyxoviridae,Pneumoviridae, Rhabdoviridae, Retroviridae, and Hepadnaviridae, (2)bacteria of genera including, but not limited to, Bacillus, Bartonella,Bordetella, Borrelia, Brucella, Campylobacter, Chlamydia, Chlamydophila,Clostridium, Corynebacterium, Enterococcus, Escherichia, Francisella,Haemophilus, Helicobacter, Legionella, Leptospira, Listeria,Mycobacterium, Mycoplasma, Neisseria, Pseudomonas, Rickettsia,Salmonella, Shigella, Staphylococcus, Streptococcus, Treponema,Ureaplasma, Vibrio, and Yersinia, (3) fungi of genera including, but notlimited to, Aspergillus, Candida, Cryptococcus, Histoplasma,Pneumocystis, and Stachybotrys, and (4) protozoa and algae including,but not limited to, Prototheca wickerhami, Plasmodium, Entamoeba,Giardia, Trypanosoma brucei, Toxoplasma gondii, Acanthamoeba,Leishmania, Babesia, Balamuthia mandrillaris, Cryptosporidium,Cyclospora, and Naegleria fowler.
 17. The method of claim 16, wherein(1) contacting a biological sample that has, or may have, nucleic acidfrom a pathogen with the solution such that the nucleic acid from thebiological sample can bind to the paramagnetic beads in a container; (2)exposing the container to a magnetic field to isolate the beads from thesolution; (3) washing the beads and eluting the nucleic acid; and (4)analyzing the nucleic acid bound to the beads for the presence orabsence of pathogenic nucleic acid; wherein steps (1) and (2) areperformed without the use of a nucleic acid extraction solution otherthan the solution of step (1).
 18. The method of claim 17, with theproviso that the solution does not include a guanidine salt, sodiumiodide, an alkaline solution or an enzyme selected from the groupconsisting of proteinase K, trypsin, dispase, collagenase, cellulase,chitinase, lysozyme, lipase, zymolase, and liticase.
 19. A methodcomprising providing a solution comprising a chelating agent, an ionicdetergent, a non-ionic detergent, a salt, a cationic polymer, a pHbuffering agent, a crowding agent and paramagnetic beads; and contactingthe solution with a biological sample, wherein the biological sample isfrom a subject suspected of being infected with SARS-CoV-2 or a subjectdesiring to be tested for a SARS-CoV-2 infection.
 20. The method ofclaim 16, wherein the Coronaviridae is SARS-CoV-2.
 21. The solution ofclaim 1, wherein said solution has not been contacted with nucleic acid.22. The solution of claim 1, wherein said solution does not comprisenucleic acid.
 23. A solution consisting essentially of one or morechelating agents, one or more ionic detergents, one or more non-ionicdetergents, one or more salts, one or more cationic polymers, one ormore pH buffering agents, one or more crowding agents, paramagneticbeads and optionally one or more antimicrobial agents.